Simmons Plating System Bolt and Screw
510(k) K930353
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930353 | Date20 Jun 1995 | StatusActive |
Official records
- FDA 510(k) database K930353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Simmons Plating System Bolt and Screw is an orthopedic device used for bone fixation. It is part of a plating system designed to stabilize bone fractures or deformities during surgical procedures.
This device is supplied as a single-use or reusable component, depending on the specific model and configuration. It is available in various sizes and is intended for use in orthopedic surgical settings. The device received FDA 510(k) clearance with product code MNH.