Synthes Hamstring Loop
510(k) K003700
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003700 | Date20 Feb 2001 | 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- Withdrawn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
- HWC
- 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 Synthes Hamstring Loop is a metallic bone fixation fastener. It is designed as an implantable device consisting of a stiff wire segment or rod, which may be constructed from alloys such as cobalt-chromium-molybdenum or stainless steel.
This device is subject to FDA 510(k) clearance under the product code HWC. It is classified as a smooth or threaded metallic bone fixation fastener intended for orthopedic use.
Other devices from Synthes (Usa)
Questions
AI-generated answers, 23 Sep 2026
What is the primary clinical application for the Synthes Hamstring Loop?
This device is intended for orthopedic use as a metallic bone fixation fastener. It functions as an implantable rod or wire segment designed to provide structural support or fixation within the bone.
What materials are used to manufacture the Synthes Hamstring Loop?
The device is constructed from high-strength metallic alloys, specifically stainless steel or cobalt-chromium-molybdenum, to ensure the necessary stiffness and durability required for bone fixation.
What is the regulatory status of this device?
The Synthes Hamstring Loop has received FDA 510(k) clearance under product code HWC. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended orthopedic applications.