ProLift Expandable Spacer System 2018-0091

GUDID 00190837066208

Paddle Distractor / Shaver, 11mm

Life Spine, Inc.

Metallic spinal fusion cage, sterile
Primary Device ID00190837066208
NIH Device Record Key641ee9c0-765f-43fc-a41e-9496b0f5c6c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProLift Expandable Spacer System
Version Model Number2018-0091
Catalog Number2018-0091
Company DUNS183641617
Company NameLife Spine, Inc.
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 Usefalse
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
GS100190837066208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837066208]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [ProLift Expandable Spacer System]

0019083702152858-1228-1210P
0019083702151158-1228-1510P
0019083701348658-1228-1016
0019083701347958-1228-0813
001908370662532018-0096
001908370661852018-0089
001908370661472018-0055
00190837066086Paddle Shaver, 14mm
001908370660622018-0022
001908370660242018-0018
001908370659802017-0131
001908370658812017-0019
00190837065782151-212
0019083706628458-1028-0814
001908370662462018-0095
001908370662392018-0094
001908370662222018-0093
001908370662152018-0092
0019083706629158-1428-0814
0019083706627758-1024-0812
001908370662602018-0097
001908370661782018-0088
001908370661612018-0087
001908370661302018-0054
001908370661162018-0029
001908370661092018-0026
001908370660932018-0025
001908370660792018-0023
001908370660552018-0021
001908370660482018-0020
001908370660312018-0019
001908370660172018-0009
001908370660002018-0002
001908370659972017-0132
001908370659732017-0108
001908370659662017-0107
001908370659592017-0106
001908370659422017-0087
001908370659352017-0086
001908370659282017-0085
001908370659112017-0025
001908370659042017-0024
001908370658982017-0020
001908370658742017-0007
001908370658672017-0004
001908370658502016-0217
001908370658432016-0162
001908370658362016-0161
00190837065829151-999
00190837065805151-258

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