The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Modular Foot Plates.
| Device ID | K050110 |
| 510k Number | K050110 |
| Device Name: | SYNTHES (USA) LCP MODULAR FOOT PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679021000230 | K050110 | 000 |
| H6794028840 | K050110 | 000 |
| H6794028820 | K050110 | 000 |
| H6794028800 | K050110 | 000 |
| H6794028780 | K050110 | 000 |
| H6794028760 | K050110 | 000 |
| H6794028740 | K050110 | 000 |
| H6794028720 | K050110 | 000 |
| H6794028700 | K050110 | 000 |
| H6794017900 | K050110 | 000 |
| H6794017880 | K050110 | 000 |
| H6794017860 | K050110 | 000 |
| H6794017840 | K050110 | 000 |
| H6794017820 | K050110 | 000 |
| H6794028860 | K050110 | 000 |
| H6794028880 | K050110 | 000 |
| H679021000220 | K050110 | 000 |
| H679021000210 | K050110 | 000 |
| H679021000200 | K050110 | 000 |
| H679041000230 | K050110 | 000 |
| H679041000220 | K050110 | 000 |
| H679041000210 | K050110 | 000 |
| H679041000200 | K050110 | 000 |
| H6794029000 | K050110 | 000 |
| H6794028980 | K050110 | 000 |
| H6794028960 | K050110 | 000 |
| H6794028940 | K050110 | 000 |
| H6794028920 | K050110 | 000 |
| H6794028900 | K050110 | 000 |
| H6794017800 | K050110 | 000 |