The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Chronos.
| Device ID | K041350 |
| 510k Number | K041350 |
| Device Name: | SYNTHES (USA) CHRONOS |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98071005798S0 | K041350 | 000 |
| H98071000198S0 | K041350 | 000 |
| H98071000298S0 | K041350 | 000 |
| H98071000398S0 | K041350 | 000 |
| H98071001198S0 | K041350 | 000 |
| H98071001498S0 | K041350 | 000 |
| H98071004298S0 | K041350 | 000 |
| H98071004798S0 | K041350 | 000 |
| H98071005098S0 | K041350 | 000 |
| H98071000098S0 | K041350 | 000 |