FDA.reportPublic FDA data

Accufuse Cervical System

Primary DI
00810016801016
Brand
Accufuse Cervical System
Company
ABSOLUTE ADVANTAGE MEDICAL, LLC
Model
10-12-07
Catalog number
10-12-07
Device description
Cage Trial 7mm
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016801016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016801016008100168010168100168010160810016801016

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
056248579
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016801078Accufuse Cervical System10-1310-132019-04-24
00810016800002Accufuse Cervical System1P7C51P7C52019-04-24
00810016800019Accufuse Cervical System1P9C71P9C72019-04-24
00810016800026Accufuse Cervical System1P8C61P8C62019-04-24
00810016800033Accufuse Cervical System1P10C81P10C82019-04-24
00810016800040Accufuse Cervical System1P11C91P11C92019-04-24
00810016800057Accufuse Cervical System1P12C101P12C102019-04-24
00810016800064Accufuse Cervical System1P13C111P13C112019-04-24
00810016800071Accufuse Cervical System1P14C121P14C122019-04-24
00810016800088Accufuse Cervical System2P232P232019-04-24
00810016800095Accufuse Cervical System2P262P262019-04-24
00810016800101Accufuse Cervical System2P292P292019-04-24
00810016800118Accufuse Cervical System2P322P322019-04-24
00810016800125Accufuse Cervical System2P352P352019-04-24
00810016800132Accufuse Cervical System2P382P382019-04-24
00810016800149Accufuse Cervical System2P412P412019-04-24
00810016800156Accufuse Cervical System2P442P442019-04-24
00810016800163Accufuse Cervical System1P7P81P7P82019-04-24
00810016800170Accufuse Cervical System1P9P101P9P102019-04-24
00810016800187Accufuse Cervical System1P11P121P11P122019-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370419SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370464SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370471SCARLET® AC-TiSpineArt SAODP2025-11-10
07640164849645icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2025-06-02
07640164849652icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2025-06-02
07640164849669icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2025-06-02
07640164849676icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2025-06-02
07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478714SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478738SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478745SCARLET® AC-TiSpineArt SAODP2024-08-02
07640172551400icotec Cervical Cage, Inserter Sleeve, longicotec AGODP2021-09-01
07640172551417icotec Cervical Cage, Inserter Rod, longicotec AGODP2021-09-01
07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
07640140433813icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mmicotec AGODP2018-07-16
07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16