The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Axiom Total Knee Syst/acl Retain Tibial Tray/inser.
| Device ID | K926334 |
| 510k Number | K926334 |
| Device Name: | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | David A Cannistraci |
| Correspondent | David A Cannistraci 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 | 1992-12-16 |
| Decision Date | 1994-10-18 |