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FDA 510(k)

KOMPREDA

K-Number: K120597 · 2013-05-03

ApplicantCustom Spine, Inc.
Decision Date2013-05-03
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

KOMPREDA is the device name listed in this FDA 510(k) record. The listed applicant is Custom Spine, Inc.. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K120597. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOMPREDA?

KOMPREDA is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is Custom Spine, Inc.. The 510(k) number is K120597.

When did KOMPREDA receive FDA 510(k) clearance?

KOMPREDA received FDA 510(k) clearance on 2013-05-03, under 510(k) number K120597.

Who is the listed applicant for KOMPREDA?

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

What is the FDA product code for KOMPREDA?

The FDA product code for KOMPREDA is MRW.

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Other records listing Custom Spine, 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.

K111726PATHWAY AVIDK111099ISSYS LP SPINAL FIXATION SYSTEMK092904PATHWAY IVB/VBRK091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEK090566PATHWAY AVIDK080281PATHWAY

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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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