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FDA 510(k)

VIPER F2 FACET FIXATION SYSTEM

K-Number: K101762 · 2010-11-15

ApplicantDepuy Spine, Inc.
Decision Date2010-11-15
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

VIPER F2 FACET FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2010-11-15 under 510(k) number K101762. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIPER F2 FACET FIXATION SYSTEM?

VIPER F2 FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-15. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K101762.

When did VIPER F2 FACET FIXATION SYSTEM receive FDA 510(k) clearance?

VIPER F2 FACET FIXATION SYSTEM received FDA 510(k) clearance on 2010-11-15, under 510(k) number K101762.

Who is the listed applicant for VIPER F2 FACET FIXATION SYSTEM?

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

What is the FDA product code for VIPER F2 FACET FIXATION SYSTEM?

The FDA product code for VIPER F2 FACET FIXATION SYSTEM is MRW.

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Other records listing Depuy Spine, 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK110216EXPEDIUM SYSTEM, VIPER SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEM

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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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