The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for P.f.c. Modular Plus Offset Tibial Tray.
| Device ID | K984158 |
| 510k Number | K984158 |
| Device Name: | P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295252023 | K984158 | 000 |
| 10603295252016 | K984158 | 000 |
| 10603295252009 | K984158 | 000 |
| 10603295251996 | K984158 | 000 |
| 10603295251989 | K984158 | 000 |
| 10603295252030 | K984158 | 000 |