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510(k) K163315

Internal Distraction - Sterile by KLS Martin L.P. — Product Code PBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2017
Date Received
November 23, 2016
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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Other clearances for product code PBJ

  • K230211 — CranioXpand (November 21, 2023)
  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K150771 — RxG Distraction System (August 27, 2015)
  • K123885 — OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR (June 3, 2013)
  • K121304 — OSTEOMED CRANIAL DISTRACTION SYSTEM (August 22, 2012)