ARx SAI

GUDID 00190837174415

Life Spine, Inc.

Spinal bone screw, non-bioabsorbable
Primary Device ID00190837174415
NIH Device Record Keyeebb6ef4-3381-4821-b3d0-d4170d2f23e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameARx SAI
Version Model NumberNC9115-110-5
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
GS100190837174415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-03
Device Publish Date2026-01-26

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

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