The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for P.f.c. Sigma Porous Modular Keel Tibial Tray.
| Device ID | K991106 |
| 510k Number | K991106 |
| Device Name: | P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 1999-04-01 |
| Decision Date | 1999-06-09 |
| Summary: | summary |