FDA.reportPublic FDA data

INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE

Primary DI
B0382292211
Brand
INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE
Company
INCITE INNOVATION
Model
22-9221
Catalog number
22-9221
Device description
ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 12x14MM, 5 DEGREE
Published
2020-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K122008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122008000INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICEIncite Innovation, LLC2012-11-16OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0382292211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005840144
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0382272201INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722022-72202020-03-31
B0382272211INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722122-72212020-03-31
B0382272221INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722222-72222020-03-31
B0382272231INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722322-72232020-03-31
B0382272241INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722422-72242020-03-31
B0382272251INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722522-72252020-03-31
B0382292201INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-922022-92202020-03-31
B0382292221INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-922222-92222020-03-31
B0382292231INCITE INNOVATION ANCHORED CERVICAL INERBODY DEVICE22-922322-92232020-03-31
B0382292241INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-922422-92242020-03-31
B0382292251INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-922522-92252020-03-31
B038227220INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722022-72202015-10-22
B038227221INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722122-72212015-10-22
B038227222INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722222-72222015-10-22
B038227223INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722322-72232015-10-22
B038227224INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722422-72242015-10-22
B038227225INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-722522-72252015-10-22
B038229211SHORT1INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-9211-SHORT22-9211-SHORT2017-02-10
B038229212LONG1INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-9212-LONG22-9212-LONG2017-02-10
B038229220INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE22-922022-92202015-10-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
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10888857027800CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027817CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
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