InFill V2 Lateral PE

GUDID 00814729020153

PINNACLE SPINE GROUP, LLC

Interspinous spinal fixation implant Interspinous spinal fixation implant
Primary Device ID00814729020153
NIH Device Record Keyba97b164-0ba0-44c6-a50d-4f00badd42a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFill V2 Lateral PE
Version Model NumberV2-00-183508-PE
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
GS100814729020153 [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

[00814729020153]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729020153]

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 V2 Lateral PE]

00814729022249V2-13-246014-PE
00814729022232V2-13-246012-PE
00814729022225V2-10-246014-PE
00814729022218V2-10-246012-PE
00814729022201V2-10-246010-PE
00814729022195V2-07-246014-PE
00814729022188V2-07-246012-PE
00814729022171V2-07-246010-PE
00814729022164V2-00-246014-PE
00814729022157V2-00-246012-PE
00814729022140V2-00-246010-PE
00814729022133V2-00-246008-PE
00814729022126V2-13-245514-PE
00814729022119V2-13-245512-PE
00814729022102V2-10-245514-PE
00814729022096V2-10-245512-PE
00814729022089V2-10-245510-PE
00814729022072V2-07-245514-PE
00814729022065V2-07-245512-PE
00814729022058V2-07-245510-PE
00814729022041V2-00-245514-PE
00814729022034V2-00-245512-PE
00814729022027V2-00-245510-PE
00814729022010V2-00-245508-PE
00814729022003V2-13-245014-PE
00814729021990V2-13-245012-PE
00814729021983V2-10-245014-PE
00814729021976V2-10-245012-PE
00814729021969V2-10-245010-PE
00814729021952V2-07-245014-PE
00814729021945V2-07-245012-PE
00814729021938V2-07-245010-PE
00814729021921V2-00-245014-PE
00814729021914V2-00-245012-PE
00814729021907V2-00-245010-PE
00814729021891V2-00-245008-PE
00814729021884V2-13-244514-PE
00814729021877V2-13-244512-PE
00814729021860V2-10-244514-PE
00814729021853V2-10-244512-PE
00814729021846V2-10-244510-PE
00814729021839V2-07-244514-PE
00814729021822V2-07-244512-PE
00814729021815V2-07-244510-PE
00814729021808V2-00-244514-PE
00814729021792V2-00-244512-PE
00814729021785V2-00-244510-PE
00814729021778V2-00-244508-PE
00814729021761V2-13-244014-PE
00814729021754V2-13-244012-PE

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