Pilot Spinal System

GUDID 00190837008864

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837008864
NIH Device Record Key971c387a-ad66-48de-9c12-acfe2b4d16c3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePilot Spinal System
Version Model Number1075-351
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837008864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837008864]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-15

On-Brand Devices [Pilot Spinal System]

00190837009663800-095
001908370096568402-120
001908370096498402-115
001908370096328402-110
001908370096258402-105
001908370096188402-100
001908370096018402-095
001908370095958402-090
001908370095888402-085
001908370095718402-080
001908370095648402-075
001908370095578402-070
001908370095408402-065
001908370095338400-120
001908370095268400-115
001908370095198400-110
001908370095028400-105
001908370094968400-100
001908370094898400-095
001908370094728400-090
001908370094658400-085
001908370094588400-080
001908370094418400-075
001908370094348400-070
001908370094278400-065
001908370094108400-060
001908370094038400-055
001908370093978400-050
001908370093808400-045
001908370093738400-040
001908370093661085-551
001908370093591085-501
001908370093421085-451
001908370093351085-401
001908370093281085-351
001908370093111085-301
001908370093048675-451
001908370092988675-401
001908370092818665-451
001908370092748665-401
001908370092678402-120B
001908370092508402-115B
001908370092438402-110B
001908370092368402-105B
001908370092298402-100B
001908370092128402-095B
001908370092058402-090B
001908370091998402-085B
001908370091828402-080B
001908370091758402-075B

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