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Osteotech Navicular and Cancellous Cannulated Screws

by Osteotech, Inc.

510(k) K950652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK950652 Date22 Jun 1995DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osteotech Navicular and Cancellous Cannulated Screws are bone fixation screws designed for orthopedic applications. These screws are cannulated and intended for use in navicular and cancellous bone fixation procedures.

The device is supplied by Osteotech, Inc. and received FDA 510(k) clearance on June 22, 1995, with product code HWC classified under Class II - Special Controls. The screws are available in various sizes as specified by the manufacturer and are intended for single-use applications in orthopedic settings.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Osteotech Navicular and Cancellous Cannulated Screws used for?

    These bone fixation screws are designed for orthopedic applications, specifically for use in navicular and cancellous bone fixation procedures.

  • Are these screws reusable or single-use?

    The screws are intended for single-use applications in orthopedic settings and should not be reused for patient safety reasons.

  • What sizes are available for these screws?

    The screws are available in various sizes as specified by the manufacturer to accommodate different clinical needs.

  • How are these screws supplied?

    The device is supplied by Osteotech, Inc. in various sizes suitable for orthopedic procedures.