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FDA 510(k)

CHAMELEON FIXATION SYSTEM

K-Number: K071420 · 2008-01-16

ApplicantSpinefrontier, Inc.
Decision Date2008-01-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

CHAMELEON FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2008-01-16 under 510(k) number K071420. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAMELEON FIXATION SYSTEM?

CHAMELEON FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-16. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K071420.

When did CHAMELEON FIXATION SYSTEM receive FDA 510(k) clearance?

CHAMELEON FIXATION SYSTEM received FDA 510(k) clearance on 2008-01-16, under 510(k) number K071420.

Who is the listed applicant for CHAMELEON FIXATION SYSTEM?

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

What is the FDA product code for CHAMELEON FIXATION SYSTEM?

The FDA product code for CHAMELEON FIXATION SYSTEM is MRW.

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Other records listing Spinefrontier, 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.

K193106SpineFrontier Lumbar Interbody Fusion Device SystemK172484A-CIFT SoloFuseK132740SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEMK123164SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMK121060SPINE FRONTIER INDUS ACP SYSTEMK113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION 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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