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FDA 510(k)

LINK(TM) External Fixator

K-Number: K240049 · 2024-05-29

ApplicantMetric Medical Devices, Inc.
Decision Date2024-05-29
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK(TM) External Fixator is the device name listed in this FDA 510(k) record. The listed applicant is Metric Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K240049. 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 LINK(TM) External Fixator?

LINK(TM) External Fixator is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Metric Medical Devices, Inc.. The 510(k) number is K240049.

When did LINK(TM) External Fixator receive FDA 510(k) clearance?

LINK(TM) External Fixator received FDA 510(k) clearance on 2024-05-29, under 510(k) number K240049.

Who is the listed applicant for LINK(TM) External Fixator?

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

What is the FDA product code for LINK(TM) External Fixator?

The FDA product code for LINK(TM) External Fixator is KTT.

Other records listing Metric Medical Devices, 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.

K152627IFS Fixation Scaffold System

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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