The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Mark I Total Knee Sys. Arthroplasty.
| Device ID | K832302 |
| 510k Number | K832302 |
| Device Name: | MARK I TOTAL KNEE SYS. ARTHROPLASTY |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| Applicant | ADVANCED BIOSEARCH ASSN. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | MBV |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-14 |
| Decision Date | 1983-08-16 |