FDA.reportPublic FDA data

SCARLET AC-T INSTRUMENTATION

Primary DI
07640151092252
Brand
SCARLET AC-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IC 3S 07-N
Catalog number
SCA-IC 3S 07-N
Device description
Trial H07 - H08 Small - Lordotic
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
07640151092252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640151092252076401510922527640151092252

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
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
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
07640221370860SCALASLA-BX 20 02-N2026-07-24
07640221373663SCALASLA-IN 01 01-N2026-07-24
07640221373670SCALASLA-IN 01 02-N2026-07-24
07640221373687SCALASLA-IN 02 00-N2026-07-24
07640221373694SCALASLA-IN 03 01-N2026-07-24
07640221373700SCALASLA-IN 03 02-N2026-07-24
07640221373717SCALASLA-IN 04 01-N2026-07-24
07640221373724SCALASLA-IN 04 02-N2026-07-24
07640221373731SCALASLA-IN 04 03-N2026-07-24
07640221373748SCALASLA-IN 05 01-N2026-07-24
07640221373755SCALASLA-IN 05 02-N2026-07-24
07640221373762SCALASLA-IN 05 03-N2026-07-24
07640221373779SCALASLA-IN 06 01-N2026-07-24
07640221373786SCALASLA-IN 06 02-N2026-07-24
07640221373793SCALASLA-IN 06 03-N2026-07-24
07640332476345PERLA ®NAV-IN BR 00-NNAV-IN BR 00-N2025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719G45170Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
M719G45180Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
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