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FDA 510(k)

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

K-Number: K030485 · 2003-12-03

ApplicantNewmedical Technology, Inc.
Decision Date2003-12-03
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Newmedical Technology, Inc.. It received FDA 510(k) clearance on 2003-12-03 under 510(k) number K030485. 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 NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR?

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR is a medical device that received FDA 510(k) clearance on 2003-12-03. The listed applicant is Newmedical Technology, Inc.. The 510(k) number is K030485.

When did NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR receive FDA 510(k) clearance?

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR received FDA 510(k) clearance on 2003-12-03, under 510(k) number K030485.

Who is the listed applicant for NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR?

The FDA 510(k) record lists Newmedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR?

The FDA product code for NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR is MQN.

Related Clinical Trials

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.

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Other records listing Newmedical Technology, Inc. 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.

K041704NEWGEL AND NEWGEL PLUS EK040064NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

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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