FDA 510(k)

Internal Distraction - Sterile

K-Number: K161470 · 2016-12-01

Decision Date2016-12-01

Product CodeMQN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Internal Distraction - Sterile is the device name listed in this FDA 510(k) record. The listed applicant is KLS Martin L.P.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K161470. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Internal Distraction - Sterile?

Internal Distraction - Sterile is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is KLS Martin L.P.. The 510(k) number is K161470.

When did Internal Distraction - Sterile receive FDA 510(k) clearance?

Internal Distraction - Sterile received FDA 510(k) clearance on 2016-12-01, under 510(k) number K161470.

Who is the listed applicant for Internal Distraction - Sterile?

The FDA 510(k) record lists KLS Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Internal Distraction - Sterile?

The FDA product code for Internal Distraction - Sterile is MQN.

Other records listing KLS Martin L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254162KLS Martin Ixos System K253660KLS Martin Pure Pectus System K250988KLS Martin Pure Pectus System K250865KLS Martin IPS Forearm System K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE K250620KLS Martin Ixos System

View all 32 devices →

Related Devices (Code: MQN)

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC K181504Stryker Pediatric Mandibular Distractor 2Stryker K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.