The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Condylar Prosthesis Of Mandible W/head.
| Device ID | K840955 |
| 510k Number | K840955 |
| Device Name: | CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-05 |
| Decision Date | 1984-06-19 |