InFill Graft Delivery System (Modified)

GUDID 00814729026162

PINNACLE SPINE GROUP, LLC

Orthopaedic cement dispenser Orthopaedic cement dispenser
Primary Device ID00814729026162
NIH Device Record Keyd4e5c413-3284-4580-ab9e-618dc9e1e8e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameInFill Graft Delivery System (Modified)
Version Model Number99-0520
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
GS100814729026162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814729026162]

Radiation Sterilization;Moist Heat or Steam Sterilization


[00814729026162]

Radiation Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-26

Devices Manufactured by PINNACLE SPINE GROUP, LLC

00814729020009 - InFill V2 Lateral PE2019-04-23
00814729020016 - InFill V2 Lateral PE2019-04-23
00814729020023 - InFill V2 Lateral PE2019-04-23
00814729020030 - InFill V2 Lateral PE2019-04-23
00814729020047 - InFill V2 Lateral PE2019-04-23
00814729020054 - InFill V2 Lateral PE2019-04-23
00814729020061 - InFill V2 Lateral PE2019-04-23
00814729020078 - InFill V2 Lateral PE2019-04-23

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