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510(k) K071628

STRYKER EXTERNAL FIXATION SYSTEM by Stryker Cmf — Product Code MQN

K071628 is an FDA 510(k) premarket notification submitted by Stryker Cmf for the device "STRYKER EXTERNAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 10, 2007. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Stryker Cmf has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2007
Date Received
June 14, 2007
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 Stryker Cmf

  • K060750 — STRYKER INJECTABLE CEMENT (April 19, 2006)

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)

FDA data resources