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FDA 510(k)

SPARTAN S3 FACET SYSTEM

K-Number: K092568 · 2009-11-17

ApplicantAmendia, Inc.
Decision Date2009-11-17
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

SPARTAN S3 FACET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2009-11-17 under 510(k) number K092568. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARTAN S3 FACET SYSTEM?

SPARTAN S3 FACET SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Amendia, Inc.. The 510(k) number is K092568.

When did SPARTAN S3 FACET SYSTEM receive FDA 510(k) clearance?

SPARTAN S3 FACET SYSTEM received FDA 510(k) clearance on 2009-11-17, under 510(k) number K092568.

Who is the listed applicant for SPARTAN S3 FACET SYSTEM?

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

What is the FDA product code for SPARTAN S3 FACET SYSTEM?

The FDA product code for SPARTAN S3 FACET SYSTEM is MRW.

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Other records listing Amendia, 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.

K160924Amendia Interbody Fusion DevicesK161842Overwatch Spine SystemK152920Savannah-T® Pedicle Screw SystemK153152Syzygy Stabilization SystemK160291Optimus ALIF SystemK152972Amendia Stand-Alone Cervical 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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