The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Dynamic Condylar Screw Or D.c.s..
| Device ID | K840954 |
| 510k Number | K840954 |
| Device Name: | DYNAMIC CONDYLAR SCREW OR D.C.S. |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) MD |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-05 |
| Decision Date | 1984-05-11 |