Home / 510(k) Clearances / K123885

510(k) K123885

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR by Osteomed LP — Product Code PBJ

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.

Other clearances by Osteomed LP

  • K212570 — OsteoPlan System (February 11, 2022)
  • K203479 — ExtremiLOCK Lateral Ankle Fusion Plates (February 24, 2021)
  • K202105 — OsteoMed ExtremiFix Mini & Small System Tray (October 29, 2020)
  • K202680 — OsteoMed ExtremiFix Mini & Small Cannulated Screw System (October 15, 2020)
  • K173391 — OsteoMed QuickFix Hybrid MMF Sterilization Tray (May 10, 2018)
  • K162542 — OsteoMed PINNACLE Driver (May 19, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K163303 — OsteoMed ExtremiFix Mid and Large Screw System (April 4, 2017)
  • K161041 — OsteoMed ExtremiLOCK Wrist Plating System (May 19, 2016)
  • K152145 — OsteoMed ExtremiLOCK Wrist Plating System (December 21, 2015)

Other clearances for product code PBJ

  • K230211 — CranioXpand (November 21, 2023)
  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K163315 — Internal Distraction - Sterile (May 5, 2017)
  • K150771 — RxG Distraction System (August 27, 2015)
  • K121304 — OSTEOMED CRANIAL DISTRACTION SYSTEM (August 22, 2012)