MQN · Class II · 21 CFR 872.4760

FDA Product Code MQN: External Mandibular Fixator And/or Distractor

Leading manufacturers include Synthes (Usa), Howmedica Corp. and Biomet, Inc..

Total

Cleared

119d

Avg days

1995

Since

Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared External Mandibular Fixator And/or Distractor Devices (Product Code MQN)

60 devices

1–24 of 60

Cleared Aug 11, 2022

KLS Martin IPS Distraction

DePuy Synthes Maxillofacial Portfolio - MR Conditional

K183113

Synthes USA Products, LLC

Dental · 124d

Cleared Sep 11, 2018

Stryker Pediatric Mandibular Distractor 2

SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM

SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT

SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM

SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR

SYNTHES MANDIBLE EXTERNAL FIXATOR

SYNTHES MANDIBLE EXTERNAL FIXATOR

SYNTHES EXTERNAL MIDFACE DISTRACTOR

SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES

SYNTHES (USA) RATCHETING DISTRACTOR

SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET

SYNTHES MINI LENGTHENING APPARATUS

SYNTHES MANDIBLE DISTRACTOR

MANDIBULAR BONE DISTRACTOR II

LORENZ MANDIBULAR DISTRACTOR

MANDIBULAR BONE DISTRACTOR

K945674

Howmedica Corp.

Dental · 196d

About Product Code MQN - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code MQN since 1995, with 60 receiving FDA clearance (average review time: 119 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Aug 11, 2022

Product Code Info

Code	MQN
Device class	Class II
CFR	21 CFR 872.4760
Panel	Dental

Verify on FDA.gov

View MQN classification on FDA.gov →