TLIF LITE

GUDID 08057432560864

SINTEA PLUSTEK SRL

Metallic spinal interbody fusion cage
Primary Device ID08057432560864
NIH Device Record Keyc7fd0dc5-1e4e-4c45-aa25-fd8c825cc441
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLIF LITE
Version Model NumberLFC-002PK3209
Company DUNS544150399
Company NameSINTEA PLUSTEK SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108057432560864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-08

On-Brand Devices [TLIF LITE]

08057432560888LFC-002PK3213
08057432560871LFC-002PK3211
08057432560864LFC-002PK3209
08057432560857LFC-002PK3207

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