InFIll Lateral Lordotic

GUDID 00814729024823

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729024823
NIH Device Record Keybcf9cd14-86f3-416a-8078-1d3745cb92d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFIll Lateral Lordotic
Version Model Number54-6008
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
GS100814729024823 [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

[00814729024823]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729024823]

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 Lordotic]

0081472902484754-6012
0081472902483054-6010
0081472902482354-6008
0081472902481654-5512
0081472902480954-5510
0081472902479354-5508
0081472902478654-5012
0081472902477954-5010
0081472902476254-5008
0081472902475554-4512
0081472902474854-4510
0081472902473154-4508
0081472902472454-4012
0081472902471754-4010
0081472902470054-4008

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