Skip to content

O'Tec Corp.

United StatesFDA 510(k) applicant, unverified

Devices
23

What O'Tec Corp. makes

O’Tec Corp. manufactures orthopedic fixation devices, including hip prostheses (such as the Thompson and Austin Moore types), intramedullary nails (e.g., Jewett hip nail), pins (Steinman threaded, Hagie, Knowles), staples (fixation and round), lag screws, and self-compressing plates for bone stabilization. Their portfolio also includes a shower commode chair (SCC22/SCC26) and a Futura femoral hip stem for hip replacement procedures.

The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.

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

Catalogue23

Newest first, rows 1-23 of 23

Search and filter all 23 devices
Skip device list

  • Thompson Type Hip Prosthesis Ref K905334

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

  • Jewett Hip Nail Ref K905346

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

  • Hagie Pin Ref K905347

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

  • Round Staple Ref K905364

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

  • Lag Screw Ref K905342

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

  • Steinman Pin, Threaded Ref K905336

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

  • Broad Self-Compressing Plate Ref K905355

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

  • Knowles Pin Ref K905344

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

  • SCC22/ SCC26 Shower Commode Chair Ref K943293

    Class I
    Active 510(k) 510(k) I

  • Fixation Staple Ref K905363

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

  • Futura Femoral Hip Stem Ref K910093

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

  • Austin Moore Type Hip Prothesis Ref K905349

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

  • K-Wire Ref K905345

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

  • Cortical Bone Screw (European Style) Ref K905357

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

  • Wheelchair Bcw 6000 Ref K883034

    Class I
    Active 510(k) 510(k) I

  • Hansen-Street Type Intramedullary Nail Ref K905348

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

  • Barbed Square Staple Ref K905362

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

  • Blade Plate Ref K905352

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

  • U.S. Type Cruciate Slot Bone Screw Ref K905333

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

  • Side Plate Ref K905338

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

  • Rush Pin Ref K905341

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

  • Cancellous Screw Ref K905358

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

  • Steinman Pin Ref K905337

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

Rows 1-23 of 23

Frequently asked questions

How many devices does O'Tec Corp. have in the registry?

The registry currently lists 23 devices for O'Tec Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list O'Tec Corp.'s devices?

Among its 23 most recently registered devices, O'Tec Corp. has devices listed in FDA 510(k) (23 devices).

What risk classes do O'Tec Corp.'s devices fall under?

Among its 23 most recently registered devices, the classes recorded for O'Tec Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from O'Tec Corp. in the registry?

The most recently registered devices listed for O'Tec Corp. include THOMPSON TYPE HIP PROSTHESIS, JEWETT HIP NAIL, HAGIE PIN and ROUND STAPLE.

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