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FDA 510(k)

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

K-Number: K034027 · 2004-02-27

ApplicantKLS-Martin L.P.
Decision Date2004-02-27
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM 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 2004-02-27 under 510(k) number K034027. 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 3DX EXTERNAL DISTRACTION SYSTEM?

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-27. The listed applicant is KLS-Martin L.P.. The 510(k) number is K034027.

When did KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM receive FDA 510(k) clearance?

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM received FDA 510(k) clearance on 2004-02-27, under 510(k) number K034027.

Who is the listed applicant for KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM?

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 3DX EXTERNAL DISTRACTION SYSTEM?

The FDA product code for KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM is MQN.

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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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsK254162KLS 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) - STERILE

View all 75 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.

K220050KLS Martin IPS DistractionKLS Martin L.P.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.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.

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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