Compression Screw
by Orthopaedic Biosystems, Ltd.
510(k) K962779
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK962779 | Date23 Aug 1996 | 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- Withdrawn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, 6 Oct 2026
A compression screw is an orthopedic device used for fracture and osteotomy fixation in periarticular applications. It provides interfragmentary compression and features a headless profile to promote healing.
The device is supplied as a sterile, single-use implant. It is indicated for use in orthopedic procedures and has received FDA 510(k) clearance under K962779.
Other devices from Orthopaedic Biosystems, Ltd.
Questions
AI-generated answers, 6 Oct 2026
What is the compression screw used for?
The compression screw is used for fracture and osteotomy fixation in periarticular applications, providing interfragmentary compression to promote bone healing.
How is the compression screw supplied and is it reusable?
The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and should not be reprocessed or reused.
What regulatory clearance does the compression screw have?
The compression screw has received FDA 510(k) clearance under K962779, indicating it is substantially equivalent to a legally marketed predicate device.