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FDA 510(k)

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

K-Number: K082795 · 2008-12-12

ApplicantInterventional Spine, Inc.
Decision Date2008-12-12
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Spine, Inc.. It received FDA 510(k) clearance on 2008-12-12 under 510(k) number K082795. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT?

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT is a medical device that received FDA 510(k) clearance on 2008-12-12. The listed applicant is Interventional Spine, Inc.. The 510(k) number is K082795.

When did SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT receive FDA 510(k) clearance?

SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT received FDA 510(k) clearance on 2008-12-12, under 510(k) number K082795.

Who is the listed applicant for SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT?

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

What is the FDA product code for SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT?

The FDA product code for SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT 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.

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Other records listing Interventional 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.

K160464Opticage(R) Expandable Interbody Fusion DeviceK132479OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00K113527OPTICAGE INTERBODY FUSION DEVICEK090767PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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