Addivation Medical Cervical Interbody Device

GUDID B804AOCS61471

Cervical Spine Interbody Device. 14 x 16mm footprint, 7mm height, 6 degrees lordosis.

ADDIVATION MEDICAL, LLC

Spinal fusion sphere
Primary Device IDB804AOCS61471
NIH Device Record Key08444649-ecd4-4de0-a497-2a6b1983168c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAddivation Medical Cervical Interbody Device
Version Model NumberAOCS6147
Company DUNS117239290
Company NameADDIVATION MEDICAL, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB804AOCS61471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-11
Device Publish Date2020-06-03

On-Brand Devices [Addivation Medical Cervical Interbody Device]

B804AOCS61491Cervical Spine Interbody Device. 14 x 16mm footprint, 9mm height, 6 degrees lordosis.
B804AOCS61481Cervical Spine Interbody Device. 14 x 16mm footprint, 8mm height, 6 degrees lordosis.
B804AOCS61471Cervical Spine Interbody Device. 14 x 16mm footprint, 7mm height, 6 degrees lordosis.
B804AOCS61461Cervical Spine Interbody Device. 14 x 16mm footprint, 6mm height, 6 degrees lordosis.
B804AOCS61451Cervical Spine Interbody Device. 14 x 16mm footprint, 5mm height, 6 degrees lordosis.
B804AOCS61421Cervical Spine Interbody Device. 14 x 16mm footprint, 12mm height, 6 degrees lordosis.
B804AOCS61411Cervical Spine Interbody Device. 14 x 16mm footprint, 11mm height, 6 degrees lordosis.
B804AOCS61401Cervical Spine Interbody Device. 14 x 16mm footprint, 10mm height, 6 degrees lordosis.
B804AOCS61291Cervical Spine Interbody Device. 12 x 14mm footprint, 9mm height, 6 degrees lordosis.
B804AOCS61281Cervical Spine Interbody Device. 12 x 14mm footprint, 8mm height, 6 degrees lordosis.
B804AOCS61271Cervical Spine Interbody Device. 12 x 14mm footprint, 7mm height, 6 degrees lordosis.
B804AOCS61261Cervical Spine Interbody Device. 12 x 14mm footprint, 6mm height, 6 degrees lordosis.
B804AOCS61251Cervical Spine Interbody Device. 12 x 14mm footprint, 5mm height, 6 degrees lordosis.
B804AOCS61221Cervical Spine Interbody Device. 12 x 14mm footprint, 12mm height, 6 degrees lordosis.
B804AOCS61211Cervical Spine Interbody Device. 12 x 14mm footprint, 11mm height, 6 degrees lordosis.
B804AOCS61201Cervical Spine Interbody Device. 12 x 14mm footprint, 10mm height, 6 degrees lordosis.

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