Block Stop Wires
by Ferguson Medical 510(k)
Active
510(k) K964087
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964087 | Date25 Nov 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- HTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
Block Stop Wires are fixation pins and wires used for orthopedic purposes. They are classified as smooth fixation pins and are designed for bone fixation procedures.
The device is supplied by Ferguson Medical and received FDA 510(k) clearance on November 25, 1996, with the K number K964087. It is a Class II device with the product code HTY and is regulated under 888.3040.
Other devices from Ferguson Medical
Questions
AI-generated answers, 26 Sep 2026
What are Block Stop Wires used for?
Block Stop Wires are fixation pins and wires specifically designed for orthopedic purposes. They are classified as smooth fixation pins that are used in bone fixation procedures to provide stability and support during surgical interventions.
How are Block Stop Wires supplied?
Block Stop Wires are supplied by Ferguson Medical, a medical device manufacturer based in Chico, California. The device is supplied in a manner appropriate for surgical use, though specific packaging details are not provided in the available information.
What is the regulatory status of Block Stop Wires?
Block Stop Wires received FDA 510(k) clearance on November 25, 1996, with the K number K964087. They are classified as a Class II device with the product code HTY and are regulated under 888.3040. The device was determined to be substantially equivalent to predicate devices.
Are Block Stop Wires single-use or reusable devices?
The available information does not specify whether Block Stop Wires are designed for single-use or multiple reuse. As a fixation device used in surgical procedures, it would typically be determined by the manufacturer's instructions and standard medical practice guidelines.