The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Hindfoot Arthrodesis Nail System.
| Device ID | K051678 |
| 510k Number | K051678 |
| Device Name: | SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67904008001S0 | K051678 | 000 |
| H67904008066S0 | K051678 | 000 |
| H67904008060S0 | K051678 | 000 |
| H67904008028S0 | K051678 | 000 |
| H67904008016S0 | K051678 | 000 |
| H67904008010S0 | K051678 | 000 |
| H67904005695S0 | K051678 | 000 |
| H679040056950 | K051678 | 000 |
| H67904005694S0 | K051678 | 000 |
| H679040056940 | K051678 | 000 |
| H67904005693S0 | K051678 | 000 |
| H679040056930 | K051678 | 000 |
| H67904005692S0 | K051678 | 000 |
| H679040056920 | K051678 | 000 |
| H67904005691S0 | K051678 | 000 |
| H67904008078S0 | K051678 | 000 |
| H67904008210S0 | K051678 | 000 |
| H679040080010 | K051678 | 000 |
| H67904008000S0 | K051678 | 000 |
| H679040080000 | K051678 | 000 |
| H67904008378S0 | K051678 | 000 |
| H67904008366S0 | K051678 | 000 |
| H67904008360S0 | K051678 | 000 |
| H67904008328S0 | K051678 | 000 |
| H67904008316S0 | K051678 | 000 |
| H67904008310S0 | K051678 | 000 |
| H67904008278S0 | K051678 | 000 |
| H67904008266S0 | K051678 | 000 |
| H67904008260S0 | K051678 | 000 |
| H67904008228S0 | K051678 | 000 |
| H67904008216S0 | K051678 | 000 |
| H679040056910 | K051678 | 000 |