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510(k) K121304

OSTEOMED CRANIAL DISTRACTION SYSTEM by Osteomed — Product Code PBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2012
Date Received
May 1, 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.

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