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FDA 510(k)

ALLY™ Facet Screws

K-Number: K163374 · 2017-02-16

ApplicantProvidence Medical Technology, Inc.
Decision Date2017-02-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

ALLY™ Facet Screws is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K163374. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLY™ Facet Screws?

ALLY™ Facet Screws is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K163374.

When did ALLY™ Facet Screws receive FDA 510(k) clearance?

ALLY™ Facet Screws received FDA 510(k) clearance on 2017-02-16, under 510(k) number K163374.

Who is the listed applicant for ALLY™ Facet Screws?

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

What is the FDA product code for ALLY™ Facet Screws?

The FDA product code for ALLY™ Facet Screws 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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

Other records listing Providence Medical Technology, 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.

K261665CORUS™ Navigation System-GNK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX ImplantK251060CORUS™ Navigation System-GXK251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantK241035PMT Posterior Cervical Stabilization System (PCSS)

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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.

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 MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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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