10mm x 24mm x 13mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted

GUDID 00190837018580

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00190837018580
NIH Device Record Keyae617946-9c78-4bdd-96a8-7c5d25550203
Commercial Distribution StatusIn Commercial Distribution
Brand Name10mm x 24mm x 13mm Titanium PLATEAU Interbody, 0° , Straight, Bulleted
Version Model Number52-1024-13T
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
GS100190837018580 [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

[00190837018580]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-20

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00190837169411 - TruLift 2024-02-02
00190837116248 - Aileron2023-11-16
00190837168322 - ARx2023-11-16
00190837135393 - ARx2023-10-16

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