The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Sigma Inset Patella.
| Device ID | K971652 |
| 510k Number | K971652 |
| Device Name: | P.F.C. SIGMA INSET PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | John D Ferros |
| Correspondent | John D Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1997-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295232766 | K971652 | 000 |
| 10603295232759 | K971652 | 000 |
| 10603295232742 | K971652 | 000 |