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510(k) K952847

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR by Ace Surgical Supply Co., Inc. — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1996
Date Received
June 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Ace Surgical Supply Co., Inc.

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  • K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, (September 16, 2009)
  • K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX (March 13, 2008)
  • K080074 — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX (February 14, 2008)
  • K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-910 (August 16, 2006)
  • K051381 — ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE (July 15, 2005)
  • K041759 — ACE CONNECT INTERNAL CONNECTION (July 22, 2004)
  • K021244 — ACE HA SCREW DENTAL IMPLANT SYSTEM (May 3, 2002)
  • K002075 — ACE SDS 3.75MM SCREW DENTAL IMPLANT (February 2, 2001)
  • K990140 — NORMED BONE TRANSPORT (March 25, 1999)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional (March 13, 2019)
  • K181504 — Stryker Pediatric Mandibular Distractor 2 (September 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR (March 20, 2014)
  • K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM (August 23, 2012)
  • K080458 — MIS CREST WIDENER (December 17, 2008)
  • K080542 — DISTRAX (December 15, 2008)