FDA.reportPublic FDA data

SCARLET AC-T INSTRUMENTATION

Primary DI
07640151092276
Brand
SCARLET AC-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IC 3L 05-N
Catalog number
SCA-IC 3L 05-N
Device description
Trial H05 - H06 Large - Lordotic
Published
2016-09-27
Public version status
Update
Distribution status
Not 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
07640151092276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640151092276076401510922767640151092276

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
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
00190776391720CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391737CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391744CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391751CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391768CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391775CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391782CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391799CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391805CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391812CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391829CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391836CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391843CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391850CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391867CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391874CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391881CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391898CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391904CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391911CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391928CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391935CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391942CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391959CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391966CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391973CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391980CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776391997CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392000CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11
00190776392017CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-11