InFill Lordotic TLIF

GUDID 00814729025158

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729025158
NIH Device Record Key349ff111-238c-4e99-af68-7fd67e6c392a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFill Lordotic TLIF
Version Model Number42-06-112811
Company DUNS962347980
Company NamePINNACLE SPINE GROUP, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814729025158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814729025158]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729025158]

Radiation Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-08-26

On-Brand Devices [InFill Lordotic TLIF]

0081472902529542-06-113016
0081472902528842-06-113015
0081472902527142-06-113014
0081472902526442-06-113013
0081472902525742-06-113012
0081472902524042-06-113011
0081472902523342-06-113010
0081472902522642-06-113009
0081472902521942-06-113008
0081472902520242-06-112816
0081472902519642-06-112815
0081472902518942-06-112814
0081472902517242-06-112813
0081472902516542-06-112812
0081472902515842-06-112811
0081472902514142-06-112810
0081472902513442-06-112809
0081472902512742-06-112808
0081472902511042-06-112616
0081472902510342-06-112615
0081472902509742-06-112614
0081472902508042-06-112613
0081472902507342-06-112612
0081472902506642-06-112611
0081472902505942-06-112610
0081472902504242-06-112609
0081472902503542-06-112608

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