FDA.reportPublic FDA data

AUDERE C CERVICAL IMPLANT 5MM X 6°

Primary DI
00857215007887
Brand
AUDERE C CERVICAL IMPLANT 5MM X 6°
Company
MET 1 TECHNOLOGIES, LLC
Model
40050006
Catalog number
40050006
Device description
THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
Published
2017-07-10
Public version status
Update
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
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
00857215007887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857215007887008572150078878572150078870857215007887

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic 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 a ceramic material [e.g., silicon nitride] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9154726762yone@ldmedicalprods.com

Regulatory Flags#

DUNS number
080474650
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819824024129CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010012600100122019-03-06
00819824024136CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010014600100142019-03-06
00819824024143CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010016600100162019-03-06
00819824024150CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010018600100182019-03-06
00819824024167CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010020600100202019-03-06
00819824024174CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010022600100222019-03-06
00819824024181CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010024600100242019-03-06
00819824024198CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020024600200242019-03-06
00819824024204CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020026600200262019-03-06
00819824024211CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020028600200282019-03-06
00819824024228CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020030600200302019-03-06
00819824024235CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020032600200322019-03-06
00819824024242CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020034600200342019-03-06
00819824024259CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020037600200372019-03-06
00819824024266CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020040600200402019-03-06
00819824024273CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020043600200432019-03-06
00819824024280CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020046600200462019-03-06
00819824024297CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030039600300392019-03-06
00819824024303CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030042600300422019-03-06
00819824024310CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030045600300452019-03-06

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