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FDA 510(k)

RAPTOR FACET FIXATION SYSTEM

K-Number: K110170 · 2011-11-28

ApplicantAlphatec Spine, Inc.
Decision Date2011-11-28
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

RAPTOR FACET FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2011-11-28 under 510(k) number K110170. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPTOR FACET FIXATION SYSTEM?

RAPTOR FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-28. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K110170.

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

RAPTOR FACET FIXATION SYSTEM received FDA 510(k) clearance on 2011-11-28, under 510(k) number K110170.

Who is the listed applicant for RAPTOR FACET FIXATION SYSTEM?

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

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

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

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Other records listing Alphatec Spine, Inc. as applicant

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K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253216IntraOp Alignment System; CONTOUR3D Bending SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

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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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