FDA.reportPublic FDA data

Endeavor™ Stand-Alone Cervical

Primary DI
M71151010
Brand
Endeavor™ Stand-Alone Cervical
Company
INNO Holdings, Inc.
Model
51-01
Device description
Cover Screw, SA Cervical, Ti 6Al 4V (ELI)
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250076000Endeavor™ Stand-Alone Cervical IBF SystemInnovasis2025-09-25OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M71151010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711LB0720L-Box®LB-072LB-0722019-07-05
M711LB0730L-Box®LB-073LB-0732019-07-05
M711LB1340L-Box®LB-134LB-1342019-07-05
M711LB1350L-Box®LB-135LB-1352019-07-05
M711LS5530TruView™LS-5532022-03-31
M711511409070Endeavor™ Stand-Alone Cervical51-1409072026-05-01
M711511406070Endeavor™ Stand-Alone Cervical51-1406072026-04-30
M711511407070Endeavor™ Stand-Alone Cervical51-1407072026-04-30
M711511407120Endeavor™ Stand-Alone Cervical51-1407122026-04-30
M711511408070Endeavor™ Stand-Alone Cervical51-1408072026-04-30
M711511408120Endeavor™ Stand-Alone Cervical51-1408122026-04-30
M711511409120Endeavor™ Stand-Alone Cervical51-1409122026-04-30
M711AXTI55350AxTiHA®AXTi5535AXTi55352026-03-31
M711AXTI55400AxTiHA®AXTi5540AXTi55402026-03-31
M711AXTI65350AxTiHA®AXTi6535AXTi65352026-03-31
M711AXTI65400AxTiHA®AXTi6540AXTi65402026-03-31
M711LS7980Navigation - Vector™ G-ELS-7982026-03-31
M711LA1120Excella®LA-1122024-01-31
M711LA1130Excella®LA-1132024-01-31
M711CI1000Opteryx®CI-100CI-1002018-01-31

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Primary DI, Brand, Company table
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