The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Curved Plates.
| Device ID | K041911 |
| 510k Number | K041911 |
| Device Name: | SYNTHES (USA) LCP CURVED PLATES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-15 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902001332S0 | K041911 | 000 |
| H679020013060 | K041911 | 000 |
| H67902001304S0 | K041911 | 000 |
| H679020013040 | K041911 | 000 |
| H67902001302S0 | K041911 | 000 |
| H679020013020 | K041911 | 000 |
| H67902001300S0 | K041911 | 000 |
| H679020013000 | K041911 | 000 |
| H679226762S0 | K041911 | 000 |
| H679226742S0 | K041911 | 000 |
| H679226722S0 | K041911 | 000 |
| H679226702S0 | K041911 | 000 |
| H679426762S0 | K041911 | 000 |
| H679426742S0 | K041911 | 000 |
| H679426722S0 | K041911 | 000 |
| H67902001306S0 | K041911 | 000 |
| H679020013080 | K041911 | 000 |
| H67902001330S0 | K041911 | 000 |
| H67902001328S0 | K041911 | 000 |
| H679020013280 | K041911 | 000 |
| H67902001326S0 | K041911 | 000 |
| H679020013260 | K041911 | 000 |
| H67902001324S0 | K041911 | 000 |
| H679020013240 | K041911 | 000 |
| H67902001322S0 | K041911 | 000 |
| H679020013220 | K041911 | 000 |
| H67902001320S0 | K041911 | 000 |
| H679020013200 | K041911 | 000 |
| H67902001312S0 | K041911 | 000 |
| H67902001310S0 | K041911 | 000 |
| H67902001308S0 | K041911 | 000 |
| H679426702S0 | K041911 | 000 |