FDA.reportPublic FDA data

SCARLET® AC-T Secured Anterior Cervical Cage

Primary DI
07640185341807
Brand
SCARLET® AC-T Secured Anterior Cervical Cage
Company
SpineArt SA
Model
SCA-RE 35 18-S
Catalog number
SCA-RE 35 18-S
Device description
Self-drilling cervical screw
Published
2019-03-08
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
K190322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190322000SCARLET® AC-T Secured Anterior Cervical CageSpineart2019-03-04ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640185341807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640185341807076401853418077640185341807

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter3.5Millimeter

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
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
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19