FDA.reportPublic FDA data

SCARLET® AC-Ti

Primary DI
07640332478158
Brand
SCARLET® AC-Ti
Company
SpineArt SA
Model
SCA-00 LL 10-N
Catalog number
SCA-00 LL 10-N
Device description
LORDOTIC SMOOTH TRIAL
Published
2024-08-06
Public version status
Update
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
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
K240699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240699000SCARLET® AC-TiSpineart SA2024-05-10OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640332478158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640332478158076403324781587640332478158

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth14Millimeter
Height10Millimeter
Width17Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
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
07640139343079BAGUERA® CCDP-IN 00 03-N2026-08-19
07640221370525BAGUERA® CCDP-IN 00 07-N2026-08-19
07640221370532BAGUERA® CCDP-IN 00 06-N2026-08-19
07640221370549BAGUERA® CCDP-IN 61 00-N2026-08-19
07640221370556BAGUERA® CCDP-IN 60 01-N2026-08-19
07640221370563BAGUERA® CCDP-IN SM 05-N2026-08-19
07640221370570BAGUERA® CCDP-IN ME 05-N2026-08-19
07640221370587BAGUERA® CCDP-IN LA 05-N2026-08-19
07640221370594BAGUERA® CCDP-IN SM 06-N2026-08-19
07640221370600BAGUERA® CCDP-IN ME 06-N2026-08-19
07640221370617BAGUERA® CCDP-IN LA 06-N2026-08-19
07640221370624BAGUERA® CCDP-IN 00 08-N2026-08-19
07640221370631BAGUERA® CCDP-BX 20 01-N2026-08-19
07640221370648BAGUERA® CCDP-BX 20 02-N2026-08-19
07640221370655BAGUERA® CLID-BX 16 00-N2026-08-19
07640221370877BAGUERA® CCDP-BX 10 03-N2026-08-19
07640332471623PERLA TL NAVNAV-IN 51 31-NNAV-IN 51 31-N2025-11-20
07640332476338PERLA ®AST-IN EC 00-NAST-IN EC 00-N2025-11-20
07640221370846SCALASLA-BX 20 00-N2026-07-24
07640221370853SCALASLA-BX 20 01-N2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-18
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325954ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325985ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17
00810216325992ZSAlign Cervical Interbody System-Spacer-WedgeZsfab, Inc.OVE2026-08-17