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FDA 510(k)

VENUS FACET SCREW SYSTEM

K-Number: K120340 · 2012-10-19

ApplicantApollo Spine, Inc.
Decision Date2012-10-19
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

VENUS FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Spine, Inc.. It received FDA 510(k) clearance on 2012-10-19 under 510(k) number K120340. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENUS FACET SCREW SYSTEM?

VENUS FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Apollo Spine, Inc.. The 510(k) number is K120340.

When did VENUS FACET SCREW SYSTEM receive FDA 510(k) clearance?

VENUS FACET SCREW SYSTEM received FDA 510(k) clearance on 2012-10-19, under 510(k) number K120340.

Who is the listed applicant for VENUS FACET SCREW SYSTEM?

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

What is the FDA product code for VENUS FACET SCREW SYSTEM?

The FDA product code for VENUS FACET SCREW SYSTEM is MRW.

Related Clinical Trials

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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Other records listing Apollo 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.

K102636ZENITH PEDICLE SYSTEMK102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARK101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALK090751COMET ANTERIOR CERVICAL PLATE SYSTEMK082504APOLLO ANTERIOR CERVICAL PLATE SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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