FDA.reportPublic FDA data

SCARLET AC-T INSTRUMENTATION

Primary DI
07640178972230
Brand
SCARLET AC-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IC 4L 09-N
Catalog number
SCA-IC 4L 09-N
Device description
Rasp Trial H09 - H10 Large - Lordotic
Published
2018-04-09
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
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
07640178972230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178972230076401789722307640178972230

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
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
07640221370921BAGUERA® CBAG-CT 14 05-S2026-08-21
07640221370938BAGUERA® CBAG-CT 14 06-S2026-08-21
07640221370945BAGUERA® CBAG-CT 14 07-S2026-08-21
07640221370952BAGUERA® CBAG-CT 16 05-S2026-08-21
07640221370969BAGUERA® CBAG-CT 16 06-S2026-08-21
07640221370976BAGUERA® CBAG-CT 16 07-S2026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
07613327506518Anchor CStryker CorporationOVE2019-12-18
10888857027534CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027541CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027558CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027572CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027589CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027596CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027756CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027763CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027770CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027794CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027800CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027817CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027978CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
04546540679147AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679154AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679161AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679178AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679185AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679192AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679208AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711599AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711605AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711612AVS Anchor-CStryker CorporationOVE2016-09-24