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510(k) K170818

Craniomaxillofacial Distraction System (CMFD) by Synthes USA Products, LLC — Product Code PBJ

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.

Other clearances by Synthes USA Products, LLC

  • K180541 — DePuy Synthes 2.0 mm Quick Insertion Screws (November 21, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K170654 — USS System (March 29, 2017)
  • K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated S (February 16, 2017)
  • K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (November 1, 2016)
  • K151276 — DePuy Synthes T-PAL Ti Spacer (June 18, 2015)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System (January 20, 2015)
  • K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (September 25, 2014)
  • K133698 — SYNAPSE SYSTEM (January 16, 2014)

Other clearances for product code PBJ

  • K230211 — CranioXpand (November 21, 2023)
  • 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)