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FDA 510(k)

X-Fix Line Additions

K-Number: K151881 · 2016-03-24

ApplicantVilex IN Tennessee, Inc.
Decision Date2016-03-24
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-Fix Line Additions is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K151881. 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 X-Fix Line Additions?

X-Fix Line Additions is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K151881.

When did X-Fix Line Additions receive FDA 510(k) clearance?

X-Fix Line Additions received FDA 510(k) clearance on 2016-03-24, under 510(k) number K151881.

Who is the listed applicant for X-Fix Line Additions?

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

What is the FDA product code for X-Fix Line Additions?

The FDA product code for X-Fix Line Additions is KTT.

Other records listing Vilex IN Tennessee, 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.

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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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