FDA.reportPublic FDA data

Addivation Medical Cervical Interbody Device

Primary DI
B804AOCS61261
Brand
Addivation Medical Cervical Interbody Device
Company
ADDIVATION MEDICAL, LLC
Model
AOCS6126
Device description
Cervical Spine Interbody Device. 12 x 14mm footprint, 6mm height, 6 degrees lordosis.
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190291000Addivation Medical Cervical Interbody SystemAddivation Medical, LLC2019-07-30ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B804AOCS61261PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fusion sphereA sterile implantable metal sphere used to stabilize interspinous processes from L3 to S1 to promote intervertebral body fusion. It is inserted into the disc space between two vertebral bodies, and is specifically designed to be used with a bone graft to hold the bones in alignment while they heal and fuse. The device is typically made of a high-grade medical cobalt-chrome (Co-Cr) or Cobalt-Chrome-Molybdenum (Co-Cr-Mo).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117239290
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B804AOCS61201Addivation Medical Cervical Interbody DeviceAOCS61202020-06-03
B804AOCS61211Addivation Medical Cervical Interbody DeviceAOCS61212020-06-03
B804AOCS61221Addivation Medical Cervical Interbody DeviceAOCS61222020-06-03
B804AOCS61251Addivation Medical Cervical Interbody DeviceAOCS61252020-06-03
B804AOCS61271Addivation Medical Cervical Interbody DeviceAOCS61272020-06-03
B804AOCS61281Addivation Medical Cervical Interbody DeviceAOCS61282020-06-03
B804AOCS61291Addivation Medical Cervical Interbody DeviceAOCS61292020-06-03
B804AOCS61401Addivation Medical Cervical Interbody DeviceAOCS61402020-06-03
B804AOCS61411Addivation Medical Cervical Interbody DeviceAOCS61412020-06-03
B804AOCS61421Addivation Medical Cervical Interbody DeviceAOCS61422020-06-03
B804AOCS61451Addivation Medical Cervical Interbody DeviceAOCS61452020-06-03
B804AOCS61461Addivation Medical Cervical Interbody DeviceAOCS61462020-06-03
B804AOCS61471Addivation Medical Cervical Interbody DeviceAOCS61472020-06-03
B804AOCS61481Addivation Medical Cervical Interbody DeviceAOCS61482020-06-03
B804AOCS61491Addivation Medical Cervical Interbody DeviceAOCS61492020-06-03

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