The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.0 Mm Craniofacial Locking Plates.
| Device ID | K033065 |
| 510k Number | K033065 |
| Device Name: | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie Smith |
| Correspondent | Bonnie Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-10-29 |
| Summary: | summary |