FDA.reportPublic FDA data

SCARLET® AC-Ti

Primary DI
07640332478585
Brand
SCARLET® AC-Ti
Company
SpineArt SA
Model
SCA-IC 27 00-N
Catalog number
SCA-IC 27 00-N
Device description
REVISION SCREWDRIVER
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
07640332478585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640332478585076403324785857640332478585

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
07640139342287Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 08-SDYN-BS 22 08-S2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 10-SDYN-BS 22 10-S2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 12-SDYN-BS 22 12-S2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 14-SDYN-BS 22 14-S2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 16-SDYN-BS 22 16-S2018-03-12
07640151087500BGran® Synthetic Osteoconductive ScaffoldBGS-005BGS-0052017-09-18
07640151087517BGran® Synthetic Osteoconductive ScaffoldBGS-010BGS-0102017-09-18
07640151087524BGran® Synthetic Osteoconductive ScaffoldBGS-015BGS-0152017-09-18
07640151087531BGran® Synthetic Osteoconductive ScaffoldBGS-030BGS-0302017-09-18
07640151087654BGran® Synthetic Osteoconductive ScaffoldBGF-001BGF-0012017-09-18
07640151087661BGran® Synthetic Osteoconductive ScaffoldBGF-005BGF-0052017-09-18
07640151087678BGran® Synthetic Osteoconductive ScaffoldBGF-010BGF-0102017-09-18
07640151087685BGran® Synthetic Osteoconductive ScaffoldBGL-015BGL-0152017-09-18
07640151087692BGran® Synthetic Osteoconductive ScaffoldBGL-030BGL-0302017-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B06234500010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500030Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500040Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500050Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500052Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500053Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500054Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29