The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 5.0mm/7.3mm Crimp Positioning Pins.
| Device ID | K081205 |
| 510k Number | K081205 |
| Device Name: | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-29 |
| Decision Date | 2008-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902221006S0 | K081205 | 000 |
| H67902221005S0 | K081205 | 000 |
| H67904221005S0 | K081205 | 000 |