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Synthes Spine Co.Lp

United StatesFDA 510(k) applicant, unverified

Devices
18

What Synthes Spine Co.Lp makes

Synthes Spine Co. LP manufactures spinal fixation and fusion systems, including anterior and posterior screw-rod constructs, interbody cages, and modular instrumentation for cervical, thoracic, and lumbar applications. Products like the SYNTHES ANTEGRA and SYNEX II systems are designed for internal spinal stabilization, while the SYNFIX-LR and SYNFIX-LR SPACER address interbody fusion with variable-angle or fixed-angle components. The SYNTHES OC FUSION and SYNAPSE systems provide modular platforms for complex spinal reconstructions, and the SYNTHES ZERO-P VARIABLE ANGLE system offers adjustable screw angles for tailored fixation.

All listed devices fall under Class II regulatory classification in the U.S., with authorisation via 510(k) clearance through the FDA. The company’s products are registered under the FDA 510(k) pathway, and the manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

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  • Synthes Zero-P Ref K112459

    Class II
    Active 510(k) 510(k) II

  • Synthes Zero-P Ref K072981

    Class II
    Active 510(k) 510(k) II

  • Synthes Antegra System Ref K063158

    Class II
    Active 510(k) 510(k) II

  • Synex Ii Ref K061891

    Class II
    Active 510(k) 510(k) II

  • Synfix -Lr Ref K062083

    Class II
    Active 510(k) 510(k) II

  • Synthes Oc Fusion And Synapse Systems Ref K072434

    Class II
    Active 510(k) 510(k) II

  • Synthes Zero-P Variable Angle (Va) Ref K112068

    Class II
    Active 510(k) 510(k) II

  • Synthes Xrl Ref K103320

    Class II
    Active 510(k) 510(k) II

  • Arcofix Ref K080020

    Class II
    Active 510(k) 510(k) II

  • Synthes Vectra System Ref K050451

    Class II
    Active 510(k) 510(k) II

  • Synapse System Ref K070573

    Class II
    Active 510(k) 510(k) II

  • Synfix-Lr Ref K053508

    Class II
    Active 510(k) 510(k) II

  • Synfix-Lr Spacer Ref K072253

    Class II
    Active 510(k) 510(k) II

  • Synthes Pangea Monoaxial System Ref K052151

    Class II
    Active 510(k) 510(k) II

  • Synthes Oc Fusion System Ref K053418

    Class II
    Active 510(k) 510(k) II

  • Synthes Oracle Spacer Ref K062933

    Class II
    Active 510(k) 510(k) II

  • Antegra-T Ref K081568

    Class II
    Active 510(k) 510(k) II

  • Synthes Zero-P Variable Angle (Va) Ref K121852

    Class II
    Active 510(k) 510(k) II

Rows 1-18 of 18

Frequently asked questions

How many devices does Synthes Spine Co.Lp have in the registry?

The registry currently lists 18 devices for Synthes Spine Co.Lp. Devices recorded under merged duplicate company entries are counted once.

Which registries list Synthes Spine Co.Lp's devices?

Among its 18 most recently registered devices, Synthes Spine Co.Lp has devices listed in FDA 510(k) (18 devices).

What risk classes do Synthes Spine Co.Lp's devices fall under?

Among its 18 most recently registered devices, the classes recorded for Synthes Spine Co.Lp's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Synthes Spine Co.Lp in the registry?

The most recently registered devices listed for Synthes Spine Co.Lp include SYNTHES ZERO-P, SYNTHES ANTEGRA SYSTEM, SYNEX II and SYNFIX -LR.

Generated automatically from registry data and not verified by a human reviewer.