Plateau-LO Spacer System

GUDID 00190837015671

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837015671
NIH Device Record Keyde76d62e-5511-4867-890b-82b61609f62a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-LO Spacer System
Version Model Number46-1042-1210
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837015671 [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

[00190837015671]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-12-19

On-Brand Devices [Plateau-LO Spacer System]

0019083701568846-1042-1212
0019083701567146-1042-1210
0019083701566446-1042-1208
0019083701565746-1042-712
0019083701564046-1042-710
0019083701563346-1042-708
0019083701562646-1036-1212
0019083701561946-1036-1210
0019083701560246-1036-1208
0019083701559646-1036-712
0019083701558946-1036-710
0019083701557246-1036-708
00190837028237PLATEAU-LO Interbody, 10mm x 32mm x 9mm, 12°
00190837028220PLATEAU-LO Interbody, 10mm x 32mm x 8mm, 12°
00190837028213PLATEAU-LO Interbody, 10mm x 30mm x 14mm, 12°
00190837028206PLATEAU-LO Interbody, 10mm x 30mm x 13mm, 12°
00190837028183PLATEAU-LO Interbody, 10mm x 30mm x 11mm, 12°
00190837028169PLATEAU-LO Interbody, 10mm x 30mm x 9mm, 12°
00190837028145PLATEAU-LO Interbody, 10mm x 28mm x 14mm, 12°
00190837028138PLATEAU-LO Interbody, 10mm x 28mm x 13mm, 12°
00190837028114PLATEAU-LO Interbody, 10mm x 28mm x 11mm, 12°
00190837028091PLATEAU-LO Interbody, 10mm x 28mm x 9mm, 12°
00190837028077PLATEAU-LO Interbody, 10mm x 26mm x 14mm, 12°
00190837028060PLATEAU-LO Interbody, 10mm x 26mm x 13mm, 12°
00190837028053PLATEAU-LO Interbody, 10mm x 26mm x 12mm, 12°
00190837028046PLATEAU-LO Interbody, 10mm x 26mm x 11mm, 12°
00190837028039PLATEAU-LO Interbody, 10mm x 26mm x 10mm, 12°
00190837028022PLATEAU-LO Interbody, 10mm x 26mm x 9mm, 12°
00190837028015PLATEAU-LO Interbody, 10mm x 26mm x 8mm, 12°
00190837028008PLATEAU-LO Interbody, 10mm x 24mm x 14mm, 12°
00190837027995PLATEAU-LO Interbody, 10mm x 24mm x 13mm, 12°
00190837027971PLATEAU-LO Interbody, 10mm x 24mm x 11mm, 12°
00190837027957PLATEAU-LO Interbody, 10mm x 24mm x 9mm, 12°
00190837027933PLATEAU-LO Interbody, 10mm x 42mm x 14mm, 7°
00190837027926PLATEAU-LO Interbody, 10mm x 42mm x 13mm, 7°
00190837027919PLATEAU-LO Interbody, 10mm x 42mm x 11mm, 7°
00190837027902PLATEAU-LO Interbody, 10mm x 42mm x 9mm, 7°
00190837027896PLATEAU-LO Interbody, 10mm x 40mm x 14mm, 7°
00190837027889PLATEAU-LO Interbody, 10mm x 40mm x 13mm, 7°
00190837027872PLATEAU-LO Interbody, 10mm x 40mm x 12mm, 7°
00190837027865PLATEAU-LO Interbody, 10mm x 40mm x 11mm, 7°
00190837027858PLATEAU-LO Interbody, 10mm x 40mm x 10mm, 7°
00190837027841PLATEAU-LO Interbody, 10mm x 40mm x 9mm, 7°
00190837027834PLATEAU-LO Interbody, 10mm x 40mm x 8mm, 7°
00190837027827PLATEAU-LO Interbody, 10mm x 38mm x 14mm, 7°
00190837027810PLATEAU-LO Interbody, 10mm x 38mm x 13mm, 7°
00190837027803PLATEAU-LO Interbody, 10mm x 38mm x 12mm, 7°
00190837027797PLATEAU-LO Interbody, 10mm x 38mm x 11mm, 7°
00190837027780PLATEAU-LO Interbody, 10mm x 38mm x 10mm, 7°
00190837027773PLATEAU-LO Interbody, 10mm x 38mm x 9mm, 7°

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.