FDA.reportPublic FDA data

SCARLET AC-T INSTRUMENTATION

Primary DI
07640178975729
Brand
SCARLET AC-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IC 12 10-N
Catalog number
SCA-IC 12 10-N
Device description
LOW-PROFILE IMPLANT HOLDER
Published
2019-02-12
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
K141314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141314000SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATIONSpineart2014-09-29OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178975729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178975729076401789757297640178975729

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195860030421E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030551E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030568E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030575E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030582E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030599E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030605E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030612E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030674E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030704E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030728E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030742E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030766E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030780E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030803E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030810E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030827E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030834E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030841E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030858E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030889E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030896E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030919E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030926E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030964E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20