The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Craniomaxillofacial Distraction System (cmfd).
| Device ID | K162594 |
| 510k Number | K162594 |
| Device Name: | Craniomaxillofacial Distraction System (CMFD) |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES USA PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Nicholas Fountoulakis |
| Correspondent | Nicholas Fountoulakis SYNTHES USA PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2017-05-08 |
| Summary: | summary |