510(k) K123885
K123885 is an FDA 510(k) premarket notification submitted by Osteomed LP for the device "OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR". The FDA issued a decision of Substantially Equivalent on June 3, 2013. The device falls under product code PBJ (Cranial Distraction System), a Class II device regulated under 21 CFR 882.5330. Osteomed LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2013
- Date Received
- December 18, 2012
- 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.