The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Condylar Head Add-on System.
| Device ID | K063181 |
| 510k Number | K063181 |
| Device Name: | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
| Classification | Prosthesis, Condyle, Mandibular, Temporary |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | NEI |
| CFR Regulation Number | 872.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-19 |
| Decision Date | 2007-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980044970000 | K063181 | 000 |
| H980044490400 | K063181 | 000 |
| H980044490300 | K063181 | 000 |
| H980044490200 | K063181 | 000 |
| H980044490100 | K063181 | 000 |
| H980044490000 | K063181 | 000 |