Amset Bone Screw
510(k) K911768
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911768 | Date4 Oct 1991 | 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- Withdrawn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
- Full name
- Amset(Tm) Bone Screw
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Amset Bone Screw is an orthopedic device used for bone fixation. It is classified as a screw, fixation, bone medical device. The device is used in orthopedic applications.
The Amset Bone Screw is supplied in various sizes and is intended for single-use. It is made by Advanced Med/Surg, Inc. and has received FDA 510K clearance, with a decision of Substantially Equivalent. The device is stored at the manufacturer's address in Hayward, CA.
Other devices from Advanced Med/Surg, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Amset Bone Screw used for?
The Amset Bone Screw is used for bone fixation in orthopedic applications, providing a solution for stabilizing and aligning bones during the healing process.
Is the Amset Bone Screw supplied in different sizes?
Yes, the Amset Bone Screw is supplied in various sizes to accommodate different patient needs and orthopedic procedures.
Can the Amset Bone Screw be reused?
No, the Amset Bone Screw is intended for single-use only, ensuring patient safety and preventing potential complications.
How is the Amset Bone Screw stored?
The Amset Bone Screw is stored at the manufacturer's address in Hayward, CA, ensuring proper handling and maintenance of the device.