The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Elastic Intramedullary Nail (ein) End Cap.
| Device ID | K053105 |
| 510k Number | K053105 |
| Device Name: | SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle 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 | 2005-11-04 |
| Decision Date | 2005-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679475900S0 | K053105 | 000 |
| H6794759000 | K053105 | 000 |