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 |