The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Axiom Total Knee System, Tibial Component.
| Device ID | K902259 |
| 510k Number | K902259 |
| Device Name: | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-06-18 |