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FDA 510(k)

KLS Martin IPS Distraction

K-Number: K220050 · 2022-08-11

ApplicantKLS Martin L.P.
Decision Date2022-08-11
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin IPS Distraction 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 2022-08-11 under 510(k) number K220050. 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 KLS Martin IPS Distraction?

KLS Martin IPS Distraction is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is KLS Martin L.P.. The 510(k) number is K220050.

When did KLS Martin IPS Distraction receive FDA 510(k) clearance?

KLS Martin IPS Distraction received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220050.

Who is the listed applicant for KLS Martin IPS Distraction?

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 KLS Martin IPS Distraction?

The FDA product code for KLS Martin IPS Distraction 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 SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS 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) - STERILEK250620KLS Martin Ixos System

View all 32 devices →

Related Devices (Code: MQN)

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.

K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.

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.

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