The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Olecranon Osteotomy Nailing System.
| Device ID | K073402 |
| 510k Number | K073402 |
| Device Name: | SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY 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 | 2007-12-04 |
| Decision Date | 2008-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902007002S0 | K073402 | 000 |
| H679020070020 | K073402 | 000 |
| H67902007000S0 | K073402 | 000 |