The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Second Generation Knee System.
| Device ID | K894334 |
| 510k Number | K894334 |
| Device Name: | SECOND GENERATION KNEE SYSTEM |
| 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 | 1989-07-14 |
| Decision Date | 1989-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 1283100000 | K894334 | 000 |
| 1279141800 | K894334 | 000 |
| 1279129000 | K894334 | 000 |
| 1279121800 | K894334 | 000 |
| 1279109000 | K894334 | 000 |
| 1293440000 | K894334 | 000 |
| 1293410000 | K894334 | 000 |
| 1293380000 | K894334 | 000 |
| 1293350000 | K894334 | 000 |
| 1293320000 | K894334 | 000 |
| 1293290000 | K894334 | 000 |
| 1285410000 | K894334 | 000 |
| 1285380000 | K894334 | 000 |
| 1285350000 | K894334 | 000 |
| 1285320000 | K894334 | 000 |
| 1279149000 | K894334 | 000 |
| 1279161800 | K894334 | 000 |
| 1279169000 | K894334 | 000 |
| 1274008500 | K894334 | 000 |
| 1274008000 | K894334 | 000 |
| 1274007500 | K894334 | 000 |
| 1274007000 | K894334 | 000 |
| 1274006500 | K894334 | 000 |
| 1270008500 | K894334 | 000 |
| 1270008000 | K894334 | 000 |
| 1270007500 | K894334 | 000 |
| 1270007000 | K894334 | 000 |
| 1270006500 | K894334 | 000 |
| 1270006000 | K894334 | 000 |
| 1270005500 | K894334 | 000 |
| 1279189000 | K894334 | 000 |
| 1279181800 | K894334 | 000 |
| 1285290000 | K894334 | 000 |