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FDA 510(k)

PRIMALOK FACET FIXATION SYSTEM

K-Number: K102438 · 2010-09-30

ApplicantOsteomed LP
Decision Date2010-09-30
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

PRIMALOK FACET FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2010-09-30 under 510(k) number K102438. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMALOK FACET FIXATION SYSTEM?

PRIMALOK FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-30. The listed applicant is Osteomed LP. The 510(k) number is K102438.

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

PRIMALOK FACET FIXATION SYSTEM received FDA 510(k) clearance on 2010-09-30, under 510(k) number K102438.

Who is the listed applicant for PRIMALOK FACET FIXATION SYSTEM?

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

What is the FDA product code for PRIMALOK FACET FIXATION SYSTEM?

The FDA product code for PRIMALOK FACET FIXATION SYSTEM is MRW.

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Other records listing Osteomed LP 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.

K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMK123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORK123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMK120015OSTEOMED WRIST PLATING SYSTEMK111419OSTEOMED HAND FUSION SYSTEMK111176OSTEOMED LOW PROFILE NEURO FIXATION 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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