Distrax

FDA 510(k) K080542 · John W. King

Substantially Equivalent

510(k) numberK080542

Submission

Device name
Distrax
Applicant
John W. King
Richmond, VA, US
Received
February 27, 2008
Decision date
December 15, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQN – External Mandibular Fixator And/Or Distractor
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4760
Specialty
Dental
Implant
Yes

Other 510(k)s with product code MQN

510(k)DeviceApplicantDecision
K220050KLS Martin IPS DistractionMQN · Traditional KLS Martin L.P.08/11/2022SE
K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN · Traditional Synthes (USA) Products, LLC03/13/2019SE
K181504Stryker Pediatric Mandibular Distractor 2MQN · Traditional Stryker09/11/2018SE
K162594Craniomaxillofacial Distraction System (CMFD)MQN · Traditional Synthes USA Products, LLC05/08/2017SE
K161470Internal Distraction - SterileMQN · Traditional KLS Martin L.P.12/01/2016SE
K143285Mandible External Fixator - MR ConditionalMQN · Traditional Synthes USA Products, LLC05/28/2015SE
K133398Stryker Pediatric Mandible DistractorMQN · Traditional Stryker03/20/2014SE
K121502Synthes Curvilinear Distraction SystemMQN · Traditional Synthes, Inc.08/23/2012SE
K080458Mis Crest WidenerMQN · Traditional Mis - Implant Technologies , Ltd.12/17/2008SE
K080153Synthes (USA) Curvilinear Distraction SystemMQN · Traditional Synthes (Usa)05/14/2008SE

Questions and answers

When was Distrax cleared by the FDA?

Distrax (K080542) received a 510(k) decision of Substantially Equivalent on December 15, 2008, 292 days after the submission was received.

What is the product code of K080542?

The FDA product code is MQN – External Mandibular Fixator And/Or Distractor, a Class II (moderate risk) device regulated under 21 CFR 872.4760.