FDA.reportPublic FDA data

SCARLET® AC-T Secured Anterior Cervical Cage

Primary DI
07640151085117
Brand
SCARLET® AC-T Secured Anterior Cervical Cage
Company
SpineArt SA
Model
SCA-AC TL 10-S
Catalog number
SCA-AC TL 10-S
Device description
Secured Anterior Cervical Cage / Large
Published
2015-10-01
Public version status
Update
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143214000SCARLET® AC-T Secured Anterior Cervical CageSpineart2015-02-23OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640151085117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640151085117076401510851177640151085117

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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
Depth14Millimeter
Height10Millimeter
Width17Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640139342287Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 08-SDYN-BS 22 08-S2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 10-SDYN-BS 22 10-S2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 12-SDYN-BS 22 12-S2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 14-SDYN-BS 22 14-S2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 16-SDYN-BS 22 16-S2018-03-12
07640151087500BGran® Synthetic Osteoconductive ScaffoldBGS-005BGS-0052017-09-18
07640151087517BGran® Synthetic Osteoconductive ScaffoldBGS-010BGS-0102017-09-18
07640151087524BGran® Synthetic Osteoconductive ScaffoldBGS-015BGS-0152017-09-18
07640151087531BGran® Synthetic Osteoconductive ScaffoldBGS-030BGS-0302017-09-18
07640151087654BGran® Synthetic Osteoconductive ScaffoldBGF-001BGF-0012017-09-18
07640151087661BGran® Synthetic Osteoconductive ScaffoldBGF-005BGF-0052017-09-18
07640151087678BGran® Synthetic Osteoconductive ScaffoldBGF-010BGF-0102017-09-18
07640151087685BGran® Synthetic Osteoconductive ScaffoldBGL-015BGL-0152017-09-18
07640151087692BGran® Synthetic Osteoconductive ScaffoldBGL-030BGL-0302017-09-18
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
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00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
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00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
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00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.OVE2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
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