ARx SAI

GUDID 00190837195083

Life Spine, Inc.

Spinal bone screw, non-bioabsorbable
Primary Device ID00190837195083
NIH Device Record Key348dac0d-402d-4d9a-9a5f-cf388f1b4bc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameARx SAI
Version Model Number17-125100-19
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837195083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-21
Device Publish Date2026-01-13

On-Brand Devices [ARx SAI]

0019083717538218-9570-09
0019083717523818-85100-09
0019083717519118-8580-09
0019083717517718-8570-09
0019083717521418-8590-09
0019083717563418-10590-09
0019083717561018-10580-09
0019083717544318-95100-09
0019083717542918-9590-09
0019083717540518-9580-09
0019083719613417-105100-09
0019083719466617-105100-19
0019083719681317-135125-09
0019083719680617-135120-09
0019083719679017-135115-09
0019083719678317-135110-09
0019083719677617-135105-09
0019083719676917-135100-09
0019083719660817-125125-09
0019083719659217-125120-09
0019083719658517-125115-09
0019083719657817-125110-09
0019083719656117-125105-09
0019083719655417-125100-09
0019083719654717-12595-09
0019083719653017-12590-09
0019083719652317-12585-09
0019083719651617-12580-09
0019083719650917-12575-09
0019083719649317-12570-09
0019083719648617-12565-09
0019083719647917-12560-09
0019083719646217-12555-09
0019083719645517-12550-09
0019083719644817-12545-09
0019083719643117-12540-09
0019083719642417-12535-09
0019083719641717-12530-09
0019083719640017-12525-09
0019083719633217-11595-09
0019083719632517-11590-09
0019083719533517-135120-19
0019083719532817-135115-19
0019083719531117-135110-19
0019083719530417-135105-19
0019083719529817-135100-19
0019083719513717-125125-19
0019083719512017-125120-19
0019083719511317-125115-19
0019083719510617-125110-19

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.