510(k) K170818
K170818 is an FDA 510(k) premarket notification submitted by Synthes USA Products, LLC for the device "Craniomaxillofacial Distraction System (CMFD)". The FDA issued a decision of Substantially Equivalent on December 7, 2017. The device falls under product code PBJ (Cranial Distraction System), a Class II device regulated under 21 CFR 882.5330. Synthes USA Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2017
- Date Received
- March 20, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Distraction System
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.