Your Contract Manufacturer

2 32 3Forward-thinking vision

LegheLeggereLavorateour history began in 1951, but the time has not yet come to put an end to over sixty year of passion. We are a company,

turned parts of special technology. We thus identified our aim for the futurewhich we hope it will ac-company us in a journey towards the technologi-cal advances.

originally dedicatedparts, that decided to jump into the evolutionary perspecti-ve of precisionmechanics, specializing in the production of

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Know-How Leghe Leggere Lavo-rate was born in 1951 thanks to the experience of fans of fine mechanics who decided to build a company on a human scale, with an agile and dynamic structure. These are characteristics that make the difference in the production of turned products with high technological stan-dards.

Creativity Leghe Leggere Lavorate has an innovative spirit and a specific curiosi-ty that lead to a continuous research of solu-tions and products to satisfy the Client.

Quality Leghe Leggere Lavorate put particularly attention to the quality of its pro-ducts for a totally Client satisfaction.

Know-How • Creativity • Quality4 5

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1 R & D

2 Manufacturing

3 Finishing

4 Packaging

Discover ourfull-service capabilities

Leghe Leggere Lavorate, is an industry leading Contract Manufacturer that offers fully integrated medical device manufacturing capabilities. From design and development, through the validation and production process, up to packaging and logistics.

4 The most important services we can offer

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R & DLeghe Leggere Lavorate tech-nical department is able to stu-dy and realize any kind of piece or mechanical handling sugge-sting possible technical solu-tion that, without alter the design, could reduce product costs.

In detail:• Mechanical design• FEM/FEA analysis• Technical Manual• Technical data and list of components management• Technical 2D and 3D drawings • Trasparency of data with a dedicated internet portal• Static and dynamic tests

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• Pre tendering

• Patent analysis

• Preliminary risk analysis

• Identification of essential requirements

• Drawing up project plans

• Prototyping

• Statistical testing

• Stress testing

• Clinical testing

• Osteo-integration testing

• Research on materials, components and packaging

• Chemical cleaning validation (ESCA/SEM/EDX)

• Biological cleaning validation (Bio burden e pyrogenic)

• Biocompatibility validation (Cytotoxicity)

• Sterilization cycle validation

• Packaging validation (accelerated ageing)

• Definitive technical designs

• Definitive plans and control cycles

• Definitive product specifications

• Project validation

• Establishing the definite technical file

• Presentation to the certification body for CE Mark

• CE Mark

4,70

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Descrizione: Codice Articolo:

Materiale:

Foglio: U.M.: Tolleranze generali:

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Disegnato da:

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Data: Firma:

Firma:

Trattamento

1:1 [mm]

Overmed S.r.l. sono vietate a termini di legge.Data (rev.): dello stesso senza autorizzazione scritta di

4.25mm - 17° - spalla 1,5 mmEDMUA1715

TITANIO GR 5 (ISO 5832-3)

ISO 2768-fH[mm]

Rev.01

20/12/2012

Moncone MUA per EasyLine

anodizzare verde V1001di1

10/06/2016

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Descrizione: Codice Articolo:

Materiale:

Foglio: U.M.: Tolleranze generali: burattarecon aghisuperficiale:

Disegnato da:

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N° revisione:

Data:

Scala

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Overmed S.r.l. La diffusione e riproduzioneIl presente disegno è di proprietà della ditta

Overmed S.r.l. sono vietate a termini di legge.Data (rev.):

ISO 2768-fH

Il presente disegno è di proprietà della dittaOvermed S.r.l. La diffusione e riproduzionedello stesso senza autorizzazione scritta di

revisione generale

2,05

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Nowadays companies tried to offer products and services that not only satisfy but even exceed the customers expec-tation, reducing, at the same time, their costs to be always competitive.

CAPABILITIES35 Mobile spindle CNCs with bar width from 1 mm to 25 mm

2 Five axis work centres with bar width 42 mm

3 Five axis milling center with automatic loader (Robot)

1 Quality control laboratory with 2D optical scanning ma-chines and 3D mechanical pro-bing machine (DEA)

A company with ISO 9001 and 13485 certification will be able to reach important improve-ment in terms of organizatio-nal efficiency and quality of the product minimizing wastes, avoiding errors and increasing the productivity.

Forward-thinking vision

Manufacturing Milano-Division: turning & 5 axis milling center

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Used materialsTitanium of different grades: gr.2, gr.3,gr.4, gr.5 ELI F136 and gr.5 ELI F1295

Stainless steel:303, 304, 316L, 316LVM,420-A,420B, 430, 630, etc.

Special alloys: (TZM , NILVAR , Cr Co)

Quenched and tempered steels:ST 137, ST 329, ET6 88, ET6100, X 205 Cr12 KU, ecc.

Hardening steels: 18Ni- CrMo5, 16CrNi4, C60, 100Cr6, 39NiCrMo3, ecc.

Alluminium: (all alloys t4,t5,t6, ERGALL 55, AVIONAL, ANTICORODAL, BT3).

Special plastic:Delrin, PEEK (DIN 7728 Standard), o and glass reinforced PEEK

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CAPABILITIES

3 Injection Molding Machinery with clamping force magnitu-des up to 45 metric ton.

2 Five axis milling center with automatic loader (Robot)

Injection moulding is in area ISO 7; advanced molding tech-nology that allows the produc-tion of complex components in large quantity and with limited costs.

All the raw materials used, such polyethylene, CFR Peek, Radel, PLDL, PLLA comply with medi-cal field standards. All products are marked with laser marking, punching, micro milling to allow traceability of the item.

Manufacturing San Marino-Division: Injection molding & 5 axis milling center

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• Deburring department

• Shot Peening department

• Sand blasting department

• Tumbling department

• Polishing and elettro-polishing department

• Washing and decontamination department (class ISO 5)

• Titanium elettro-polishing department

• Titanium anodizing process department (class I-II)

• Citric and nitric acid passivation department

Forward-thinking vision

Finishing

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Packaging of the productbegins in observanceof validated procedures.

For sterile products, the keypoint in this process is the cleanroom ISO 7 and ISO 8.

We can handle different type ofpackaging: blisters, tyvek pou-ches or vacuum pouches.

The packagingprocess ends with labelling.

The products are then sent forthe sterilization process by external supplier with validatedsterilization cycles.

PackagingDeliveryPunctuality

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Extremities

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Screws for :• Hallux Valgus/Osteotomies• Arthrodesis/Osteosynthesis• Flat foot correction in child or adult• Osteotomies and fractures• Stabilisation - totally intra osseous fixation• Valgus pronated congenital essential child and adolescent

Self-drilling and self-tapping, cannulated Titanium alloy Ti6AI4V. Progressive conical shape for a better compressionNo dorsal impingment.Some particular screw, implant

o pins can be realized in PLLA resorbable material with injec-tion molding technology.These products have mechani-cal properties guaranteed for at least 18 months.

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Spine:• Monoaxial and polyaxial pedicle screws• Hooks• Straight and angled bars• Cage (titanium and PEEK)

Spine

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Trauma metallic componentsmaterial: Titanium, AISI, CrCo and aluminium

TraumaTrauma:• Nailing system• LCP locking compression plate & screws• Screws systems • Hexternal fixator

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Trauma no-metallic componentsmaterial: peek, CFR peek, PLLA, PDLA

TraumaTrauma:• Plates in CFR Peek• Screws in PLLA/PDLA*• Cambre in PLLA/PDLA*• Pin in PLLA/PDLA*

* Resorbable implants have shown many advantages, for example:

• make bone consolidation easier eliminate the need to remove the synthesis device• eliminate the visual distortion due to the metal material during the MRI control• avoid the release of metal ions in bone tissues cage (titanium and PEEK)

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Dental

Maxillo

Dental and Maxillo :• Complete monophasic dental system• Complete bi-phasic dental system• Torque ratchet• Prosthetic components• Guided surgery• Cad cam solution

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Nowadays, industrial com-panies and respect for the environment should match each other. Leghe Leggere Lavorate fights against pollution thanks to a rational appro-ach regarding the three main mechanics matters: electricity and heat retrie-val, waste material dispo-sal and oil treatment.

Ecology

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Meet us! Note

Meet us!

ONLY

04-

2019

LLL

EN

Via Lucania, 23/25 20090 Buccinasco (MI) Italy

Tel. + 39 02 4571.2115/3564 Fax + 39 02 488.0012

www.legheleggere.com vendite@legheleggere.com