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FDA 510(k)

WRISTORE FIXATOR

K-Number: K012294 · 2002-03-04

ApplicantMillennium Medical Technologies, Inc.
Decision Date2002-03-04
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WRISTORE FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Medical Technologies, Inc.. It received FDA 510(k) clearance on 2002-03-04 under 510(k) number K012294. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRISTORE FIXATOR?

WRISTORE FIXATOR is a medical device that received FDA 510(k) clearance on 2002-03-04. The listed applicant is Millennium Medical Technologies, Inc.. The 510(k) number is K012294.

When did WRISTORE FIXATOR receive FDA 510(k) clearance?

WRISTORE FIXATOR received FDA 510(k) clearance on 2002-03-04, under 510(k) number K012294.

Who is the listed applicant for WRISTORE FIXATOR?

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

What is the FDA product code for WRISTORE FIXATOR?

The FDA product code for WRISTORE FIXATOR is KTT.

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Other records listing Millennium Medical Technologies, Inc. as applicant

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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