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FDA 510(k)

INTEGRA FACET FIXATION SYSTEM

K-Number: K132859 · 2013-11-18

ApplicantSeaspine, Inc.
Decision Date2013-11-18
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

INTEGRA FACET FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2013-11-18 under 510(k) number K132859. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA FACET FIXATION SYSTEM?

INTEGRA FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-18. The listed applicant is Seaspine, Inc.. The 510(k) number is K132859.

When did INTEGRA FACET FIXATION SYSTEM receive FDA 510(k) clearance?

INTEGRA FACET FIXATION SYSTEM received FDA 510(k) clearance on 2013-11-18, under 510(k) number K132859.

Who is the listed applicant for INTEGRA FACET FIXATION SYSTEM?

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

What is the FDA product code for INTEGRA FACET FIXATION SYSTEM?

The FDA product code for INTEGRA FACET FIXATION SYSTEM is MRW.

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Other records listing Seaspine, Inc. as applicant

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K231654NorthStar OCT SystemK121924INTEGRA INTERSPINOUS PROCESS SYSTEMK130830INTEGRA LAMINOPLASTY SYSTEMK122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMK112206CARDIFF ANTERIOR CERVICAL PLATE SYSTEMK111671SEASPINE MONOPOLAR PROBE SYSYEM

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Related Devices (Code: MRW)

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.

K262618Arthrex Spine Compression FT ScrewArthrex, Inc.K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc Medica

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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