The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Sigma Tibial Inserts And Co-cr Tibial Trays.
| Device ID | K032151 |
| 510k Number | K032151 |
| Device Name: | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-14 |
| Decision Date | 2003-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295064923 | K032151 | 000 |
| 10603295064916 | K032151 | 000 |
| 10603295064909 | K032151 | 000 |
| 10603295064565 | K032151 | 000 |
| 10603295063568 | K032151 | 000 |
| 10603295064893 | K032151 | 000 |
| 10603295063810 | K032151 | 000 |