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FDA 510(k)

Endeavor™ Stand-Alone Cervical IBF System

K-Number: K250076 · 2025-09-25

ApplicantInnovasis
Decision Date2025-09-25
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Endeavor™ Stand-Alone Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K250076. 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 Endeavor™ Stand-Alone Cervical IBF System?

Endeavor™ Stand-Alone Cervical IBF System is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Innovasis. The 510(k) number is K250076.

When did Endeavor™ Stand-Alone Cervical IBF System receive FDA 510(k) clearance?

Endeavor™ Stand-Alone Cervical IBF System received FDA 510(k) clearance on 2025-09-25, under 510(k) number K250076.

Who is the listed applicant for Endeavor™ Stand-Alone Cervical IBF System?

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

What is the FDA product code for Endeavor™ Stand-Alone Cervical IBF System?

The FDA product code for Endeavor™ Stand-Alone Cervical IBF System is OVE.

Related Clinical Trials

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NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Innovasis 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.

K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250603AxTiHA® Stand-Alone ALIF SystemK250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF SystemK223511Excella Navigation Instruments

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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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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