InFIll Lateral Parallel

GUDID 00814729024540

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729024540
NIH Device Record Key0eb772ad-01f9-4020-b0a8-414d0c56db63
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFIll Lateral Parallel
Version Model Number53-4508
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
GS100814729024540 [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

[00814729024540]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729024540]

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 Lateral Parallel]

0081472902469453-6014
0081472902468753-6012
0081472902467053-6010
0081472902466353-6008
0081472902465653-5514
0081472902464953-5512
0081472902463253-5510
0081472902462553-5508
0081472902461853-5014
0081472902460153-5012
0081472902459553-5010
0081472902458853-5008
0081472902457153-4514
0081472902456453-4512
0081472902455753-4510
0081472902454053-4508
0081472902453353-4014
0081472902452653-4012
0081472902451953-4010
0081472902450253-4008

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