Tendon Harvester
by Concept, Inc. 510(k)
Active
510(k) K880414
Overview
The Tendon Harvester is a surgical instrument designed for the retrieval of semitendinosus and gracilis tendons. It is intended for use during ACL and PCL reconstruction procedures to obtain grafts of known lengths while minimizing trauma to surrounding soft tissue.
This device is supplied by Concept, Inc. and has received FDA 510(k) clearance under K880414. It is categorized under product code HRX for use in orthopedic surgical settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880414 | Date25 Mar 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent