InFill Contour TLIF

GUDID 00814729025455

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729025455
NIH Device Record Keyb3ea4877-a57b-41c0-a22e-8f913ede5394
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFill Contour TLIF
Version Model Number43-05-103014
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
GS100814729025455 [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

[00814729025455]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729025455]

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 Contour TLIF]

0081472902547943-05-103016
0081472902546243-05-103015
0081472902545543-05-103014
0081472902544843-05-103013
0081472902543143-05-103012
0081472902542443-05-103011
0081472902541743-05-103010
0081472902540043-05-103009
0081472902539443-05-103008
0081472902538743-05-102616
0081472902537043-05-102615
0081472902536343-05-102614
0081472902535643-05-102613
0081472902534943-05-102612
0081472902533243-05-102611
0081472902532543-05-102610
0081472902531843-05-102609
0081472902530143-05-102608

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