FDA.report

JULIET ® Ti LL

Primary DI
07640332479704
Brand
JULIET ® Ti LL
Company
SpineArt SA
Model
JLT-MX 50 10-S
Catalog number
JLT-MX 50 10-S
Device description
LATERAL LUMBAR TI-LIFE CAGE
Published
2024-08-02
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K241321000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241321000Juliet® Ti LL Lumbar Interbody DeviceSpineart SA2024-07-18OVD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640332479704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640332479704076403324797047640332479704

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
Angle15degree
Height10Millimeter
Length50Millimeter
Width21Millimeter

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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