Osteotech Navicular and Cancellous Cannulated Screws
510(k) K950652
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK950652 | Date22 Jun 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Osteotech, Inc.
Questions
AI-generated answers, 19 Sep 2026
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.