The following data is part of a premarket notification filed by Tornier with the FDA for Kneetec Pfj&hls Kneetec Patellar Component.
| Device ID | K111970 |
| 510k Number | K111970 |
| Device Name: | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Contact | Stephanie Bernard |
| Correspondent | Stephanie Bernard TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2012-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700386937712 | K111970 | 000 |