The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Axiom Total Knee System, All Poly Tibial Tray.
| Device ID | K914230 |
| 510k Number | K914230 |
| Device Name: | AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-20 |
| Decision Date | 1991-12-16 |