The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Patellofemoral Joint Prosthesis.
| Device ID | K962190 |
| 510k Number | K962190 |
| Device Name: | PATELLOFEMORAL JOINT PROSTHESIS |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Sam Mirza |
| Correspondent | Sam Mirza INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-10-28 |
| Summary: | summary |