The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Chronos Composite.
| Device ID | K071046 |
| 510k Number | K071046 |
| Device Name: | SYNTHES CHRONOS COMPOSITE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey Dow |
| Correspondent | Jeffrey Dow SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-13 |
| Decision Date | 2007-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9810780120099S0 | K071046 | 000 |
| H9810780111199S0 | K071046 | 000 |
| H9810780111099S0 | K071046 | 000 |
| H9810780110199S0 | K071046 | 000 |
| H9810780110099S0 | K071046 | 000 |