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FDA 510(k)

PEEK PREVAIL CERVICAL INTERBODY DEVICE

K-Number: K094042 · 2010-06-30

ApplicantMedtronic Sofamor Danek
Decision Date2010-06-30
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK PREVAIL CERVICAL INTERBODY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K094042. 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 PEEK PREVAIL CERVICAL INTERBODY DEVICE?

PEEK PREVAIL CERVICAL INTERBODY DEVICE is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K094042.

When did PEEK PREVAIL CERVICAL INTERBODY DEVICE receive FDA 510(k) clearance?

PEEK PREVAIL CERVICAL INTERBODY DEVICE received FDA 510(k) clearance on 2010-06-30, under 510(k) number K094042.

Who is the listed applicant for PEEK PREVAIL CERVICAL INTERBODY DEVICE?

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

What is the FDA product code for PEEK PREVAIL CERVICAL INTERBODY DEVICE?

The FDA product code for PEEK PREVAIL CERVICAL INTERBODY DEVICE is OVE.

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Related Devices (Code: OVE)

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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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