FDA.reportPublic FDA data

SCARLET® AC-Ti

Primary DI
07640332478561
Brand
SCARLET® AC-Ti
Company
SpineArt SA
Model
SCA-IC 29 00-N
Catalog number
SCA-IC 29 00-N
Device description
ANCHOR ORIENTER
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, 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
07640332478561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640332478561076403324785617640332478561

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221373359PERLA ® TLTLF-IN 36 10-NTLF-IN 36 10-N2026-02-09
07640221373366PERLA ® TLTLF-IN 36 00-NTLF-IN 36 00-N2026-02-09
07640221373373PERLA ® TLTLF-IN 05 60-NTLF-IN 05 60-N2026-02-09
07640221373380PERLA ® TLTLF-IN 05 70-NTLF-IN 05 70-N2026-02-09
07640151082482ROMEO 2 MISMIS-IN 04 01-NMIS-IN 04 01-N2026-02-05
07640151082499ROMEO 2 MISMIS-IN 05 01-NMIS-IN 05 01-N2026-02-05
07640332477854PERLA ®SPE-IN 01 63-NSPE-IN 01 63-N2026-02-05
07640375236081Cure OPEL-C1100-950-001100-950-002026-02-05
07640450868879PERLA ® TL MIS NAVNAV-BX 30 20-NNAV-BX 30 20-N2026-02-05
07640450866479BAGUERA CLID-BX 04 00-NLID-BX 04 00-N2026-01-30
07640332471548PERLA ® TLTLF-IN 23 60-NTLF-IN 23 60-N2026-01-05
07640185349650PERLA ® TLTLF-IN 13 30-NTLF-IN 13 30-N2025-11-20
07640270064178CURE ACP7-00001-187-00001-182025-11-20
07640270064192CURE ACP7-00001-207-00001-202025-11-20
07640270064215CURE ACP7-00001-227-00001-222025-11-20
07640270064239CURE ACP7-00001-247-00001-242025-11-20
07640270064291CURE ACP7-00001-307-00001-302025-11-20
07640270064345CURE ACPS1-7-00001-20S1-7-00001-202025-11-20
07640270064475CURE ACP7-00002-307-00002-302025-11-20
07640270064499CURE ACP7-00002-327-00002-322025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00841193127521EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
10195860030421E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20