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FDA 510(k)

KYPHON ANCHOR FACET SCREW SYSTEM

K-Number: K101765 · 2010-10-22

ApplicantMedtronic Spine, LLC
Decision Date2010-10-22
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

KYPHON ANCHOR FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Spine, LLC. It received FDA 510(k) clearance on 2010-10-22 under 510(k) number K101765. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYPHON ANCHOR FACET SCREW SYSTEM?

KYPHON ANCHOR FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Medtronic Spine, LLC. The 510(k) number is K101765.

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

KYPHON ANCHOR FACET SCREW SYSTEM received FDA 510(k) clearance on 2010-10-22, under 510(k) number K101765.

Who is the listed applicant for KYPHON ANCHOR FACET SCREW SYSTEM?

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

What is the FDA product code for KYPHON ANCHOR FACET SCREW SYSTEM?

The FDA product code for KYPHON ANCHOR FACET SCREW SYSTEM is MRW.

Related Clinical Trials

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Other records listing Medtronic Spine, LLC 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.

K103231KYPHON INFLATION SYRINGE

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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