The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Condylar Head Add-on System.
| Device ID | K081747 |
| 510k Number | K081747 |
| Device Name: | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
| Classification | Prosthesis, Condyle, Mandibular, Temporary |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker 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 | 2008-06-19 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980044970010 | K081747 | 000 |