FS3 2019-0077

GUDID 00190837090890

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837090890
NIH Device Record Keyba1839e3-f966-4297-b279-e57f427812cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFS3
Version Model Number2019-0077
Catalog Number2019-0077
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
GS100190837090890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837090890]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

Devices Manufactured by Life Spine, Inc.

00190837169428 - TruLift 1-Hole Plate2024-03-28
00190837147327 - ProLift Lateral2024-03-21
00190837171674 - ProLift Lateral2024-03-21
00190837138974 - ProLift2024-02-08
00190837169411 - TruLift 2024-02-02
00190837116248 - Aileron2023-11-16
00190837168322 - ARx2023-11-16
00190837135393 - ARx2023-10-16

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