FDA.report

SCARLET® AC-Ti

Primary DI
07640332478899
Brand
SCARLET® AC-Ti
Company
SpineArt SA
Model
SCA-TL SM 08-S
Catalog number
SCA-TL SM 08-S
Device description
SECURED ANTERIOR CERVICAL CAGE - LORDOTIC
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions

SubmissionSupplement
K240699000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240699000SCARLET® AC-TiSpineart SA2024-05-10OVE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640332478899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640332478899076403324788997640332478899

GMDN Terms

TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes

TypeValueUnit
Angle7degree
Depth12Millimeter
Height8Millimeter
Width15Millimeter

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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