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 | K170818 |
| 510k Number | K170818 |
| Device Name: | Craniomaxillofacial Distraction System (CMFD) |
| Classification | Cranial Distraction System |
| 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 | PBJ |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-12-07 |
| Summary: | summary |