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FDA 510(k)

INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)

K-Number: K081194 · 2008-05-29

ApplicantRsb Spine, LLC
Decision Date2008-05-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) is the device name listed in this FDA 510(k) record. The listed applicant is Rsb Spine, LLC. It received FDA 510(k) clearance on 2008-05-29 under 510(k) number K081194. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)?

INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Rsb Spine, LLC. The 510(k) number is K081194.

When did INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) receive FDA 510(k) clearance?

INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) received FDA 510(k) clearance on 2008-05-29, under 510(k) number K081194.

Who is the listed applicant for INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)?

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

What is the FDA product code for INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)?

The FDA product code for INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) is OVE.

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Other records listing Rsb Spine, LLC 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.

K092540C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACERK092070INTERPLATE CK071922INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGCK071372MODIFICATION TO: INTERPLATE VBR SYSTEMK070316INTERPLATE VBR SYSTEMK061401INTERPLATE VBR SYSTEM

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Related Devices (Code: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

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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