Cross Cancellous Bone Screw
by Buckman Co., Inc. 510(k)
Active
510(k) K896044
Overview
The Cross Cancellous Bone Screw is a fixation screw designed for use in cancellous bone. It is classified as a bone fixation screw within the orthopedic specialty and is intended to provide stable fixation of bone fragments.
The device received traditional FDA 510(k) clearance (K896044) on November 9, 1989, with a product code of HWC and is classified as a Class II medical device. The clearance was based on substantial equivalence for some indications, and the submission was reviewed by the Orthopedic advisory committee. No third‑party review was required.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK896044 | Date9 Nov 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SN