The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Chronos.
| Device ID | K043045 |
| 510k Number | K043045 |
| Device Name: | SYNTHES (USA) CHRONOS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2005-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98171003999S0 | K043045 | 000 |
| H67971005297S0 | K043045 | 000 |
| H67971005197S0 | K043045 | 000 |
| H67971005097S0 | K043045 | 000 |
| H67971004797S0 | K043045 | 000 |
| H67971004597S0 | K043045 | 000 |
| H67971002797S0 | K043045 | 000 |
| H67971002697S0 | K043045 | 000 |
| H67971002597S0 | K043045 | 000 |
| H67971002197S0 | K043045 | 000 |
| H67971001997S0 | K043045 | 000 |
| H67971005397S0 | K043045 | 000 |
| H67971005797S0 | K043045 | 000 |
| H98171003899S0 | K043045 | 000 |
| H98171002799S0 | K043045 | 000 |
| H98171002699S0 | K043045 | 000 |
| H98171002599S0 | K043045 | 000 |
| H98171002199S0 | K043045 | 000 |
| H98171001999S0 | K043045 | 000 |
| H98171001499S0 | K043045 | 000 |
| H98171000299S0 | K043045 | 000 |
| H67971006397S0 | K043045 | 000 |
| H67971006097S0 | K043045 | 000 |
| H67971001497S0 | K043045 | 000 |