PLIF LITE

GUDID 08057432560802

SINTEA PLUSTEK SRL

Metallic spinal interbody fusion cage
Primary Device ID08057432560802
NIH Device Record Key20f070c8-fdb4-4c0d-8e13-4396787389a8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLIF LITE
Version Model NumberLFC-001PK2208
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
GS108057432560802 [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 [PLIF LITE]

08057432565722LFC-001PK2616
08057432565715LFC-001PK2614
08057432565708LFC-001PK2612
08057432565692LFC-001PK2610
08057432565685LFC-001PK2608
08057432560840LFC-001PK2216
08057432560833LFC-001PK2214
08057432560826LFC-001PK2212
08057432560819LFC-001PK2210
08057432560802LFC-001PK2208

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