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FDA 510(k)

ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL

K-Number: K101588 · 2011-01-07

ApplicantApollo Spine, Inc.
Decision Date2011-01-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Spine, Inc.. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K101588. 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 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL?

ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Apollo Spine, Inc.. The 510(k) number is K101588.

When did ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL receive FDA 510(k) clearance?

ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL received FDA 510(k) clearance on 2011-01-07, under 510(k) number K101588.

Who is the listed applicant for ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL?

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

What is the FDA product code for ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL?

The FDA product code for ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL is OVE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Apollo 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.

K120340VENUS FACET SCREW SYSTEMK102636ZENITH PEDICLE SYSTEMK102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARK090751COMET ANTERIOR CERVICAL PLATE SYSTEMK082504APOLLO ANTERIOR CERVICAL PLATE SYSTEM

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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