Steinman Pin
by American Medical Specialties, Inc.
510(k) K960483
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960483 | Date9 Apr 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- Withdrawn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
- HTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Steinman Pin is an orthopedic device. It is classified under the product code HTY.
The Steinman Pin is supplied by American Medical Specialties, Inc. and has received FDA 510K authorization. The device is associated with the advisory committee description Orthopedic.
Other devices from American Medical Specialties, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Steinman Pin used for?
The Steinman Pin is an orthopedic device, but its specific use is not detailed in the provided information.
How is the Steinman Pin supplied?
The Steinman Pin is supplied by American Medical Specialties, Inc.
What regulatory authorization has the Steinman Pin received?
The Steinman Pin has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.