The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Cmf-titanium Cranio-maxillo-facial Fracture Fixation (osteosynthesis) System.
| Device ID | K946165 |
| 510k Number | K946165 |
| Device Name: | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Contact | Thomas Parker |
| Correspondent | Thomas Parker ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-19 |
| Decision Date | 1995-05-23 |