The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Plus Total Knee Syst, Titanium Tibial Peg.
| Device ID | K893040 |
| 510k Number | K893040 |
| Device Name: | ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-11-20 |