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FDA 510(k)

FACET SCREW SYSTEM

K-Number: K101284 · 2010-07-15

ApplicantNuvasive, Inc.
Decision Date2010-07-15
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K101284. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACET SCREW SYSTEM?

FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Nuvasive, Inc.. The 510(k) number is K101284.

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

FACET SCREW SYSTEM received FDA 510(k) clearance on 2010-07-15, under 510(k) number K101284.

Who is the listed applicant for FACET SCREW SYSTEM?

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

What is the FDA product code for FACET SCREW SYSTEM?

The FDA product code for FACET SCREW SYSTEM is MRW.

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Other records listing Nuvasive, Inc. as applicant

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K240507NuVasive AttraX ScaffoldK223731NuVasive Modulus-C Interbody SystemK211757Simplify DiscK173117NuVasive® VersaTie™ SystemK133052AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMK131025ARCHON ANTERIOR CERVICAL PLATE 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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