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510(k) K230211

CranioXpand by KLS-Martin L.P. — Product Code PBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
January 26, 2023
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

  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K163315 — Internal Distraction - Sterile (May 5, 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)