The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Knee Instrumentation, Condylar.
| Device ID | K781091 |
| 510k Number | K781091 |
| Device Name: | KNEE INSTRUMENTATION, CONDYLAR |
| Classification | Template |
| Applicant | BIOMET, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HWT |
| CFR Regulation Number | 888.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-03 |
| Decision Date | 1978-07-17 |