PASSIVE TENDON IMPLANT
Device Facts
| Record ID | K780320 |
|---|---|
| Device Name | PASSIVE TENDON IMPLANT |
| Applicant | Holter-Hausner Intl. |
| Product Code | HXA · Orthopedic |
| Decision Date | Mar 17, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3025 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.
