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FDA 510(k)

CHESAPEAKE (CERVICAL COMPONENTS)

K-Number: K111439 · 2011-08-24

ApplicantK2m, Inc.
Decision Date2011-08-24
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHESAPEAKE (CERVICAL COMPONENTS) is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2011-08-24 under 510(k) number K111439. 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 CHESAPEAKE (CERVICAL COMPONENTS)?

CHESAPEAKE (CERVICAL COMPONENTS) is a medical device that received FDA 510(k) clearance on 2011-08-24. The listed applicant is K2m, Inc.. The 510(k) number is K111439.

When did CHESAPEAKE (CERVICAL COMPONENTS) receive FDA 510(k) clearance?

CHESAPEAKE (CERVICAL COMPONENTS) received FDA 510(k) clearance on 2011-08-24, under 510(k) number K111439.

Who is the listed applicant for CHESAPEAKE (CERVICAL COMPONENTS)?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHESAPEAKE (CERVICAL COMPONENTS)?

The FDA product code for CHESAPEAKE (CERVICAL COMPONENTS) is OVE.

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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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