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FDA 510(k)

ARBOR External Fixation System

K-Number: K172438 · 2018-01-12

ApplicantGlobus Medical, Inc.
Decision Date2018-01-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARBOR External Fixation System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-01-12 under approval number K172438. 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 ARBOR External Fixation System?

ARBOR External Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Globus Medical, Inc.. The 510(k) number is K172438.

When was ARBOR External Fixation System approved by the FDA?

ARBOR External Fixation System received FDA 510(k) clearance on 2018-01-12, under approval number K172438.

What company makes ARBOR External Fixation System?

ARBOR External Fixation System is manufactured by Globus Medical, Inc..

What is the FDA product code for ARBOR External Fixation System?

The FDA product code for ARBOR External Fixation System is KTT.

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, 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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