GAMMA RADIATION STERILIZATION PRECEDURE
Device Facts
| Record ID | K781668 |
|---|---|
| Device Name | GAMMA RADIATION STERILIZATION PRECEDURE |
| Applicant | Cutter Laboratories, Inc. |
| Product Code | KYJ · Orthopedic |
| Decision Date | Nov 3, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3230 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.
