InFill Convex TLIF

GUDID 00814729024991

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729024991
NIH Device Record Keybcd1457a-57ee-4324-8a53-d535ff406937
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFill Convex TLIF
Version Model Number41-06-113013
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
GS100814729024991 [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

[00814729024991]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729024991]

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 Convex TLIF]

0081472902502841-06-113016
0081472902501141-06-113015
0081472902500441-06-113014
0081472902499141-06-113013
0081472902498441-06-113012
0081472902497741-06-113011
0081472902496041-06-113010
0081472902495341-06-113009
0081472902494641-06-113008
0081472902493941-06-112816
0081472902492241-06-112815
0081472902491541-06-112814
0081472902490841-06-112813
0081472902489241-06-112812
0081472902488541-06-112811
0081472902487841-06-112810
0081472902486141-06-112809
0081472902485441-06-112808

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