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 |