Plateau-C Instruments 2019-0025

GUDID 00190837032340

14mm X 11mm Rasp/Trial, 7°, 5mm, Short Stop

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837032340
NIH Device Record Keye42f874a-27d0-4be6-880c-060e4d500326
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-C Instruments
Version Model Number2019-0025
Catalog Number2019-0025
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
GS100190837032340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837032340]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [Plateau-C Instruments]

00190837032494Wedge Installer
00190837032487Disc Cutter
00190837032470DECORTICATION TUBE
00190837032463Guide Tube
00190837032456Rasp
00190837032449Access Chisel
0019083703243214mm X 11mm Rasp/Trial, 7°, 14mm, Short Stop
0019083703242514mm X 11mm Rasp/Trial, 7°, 13mm, Short Stop
0019083703241814mm X 11mm Rasp/Trial, 7°, 12mm, Short Stop
0019083703240114mm X 11mm Rasp/Trial, 7°, 11mm, Short Stop
0019083703239514mm X 11mm Rasp/Trial, 7°, 10mm, Short Stop
0019083703238814mm X 11mm Rasp/Trial, 7°, 9mm, Short Stop
0019083703237114mm X 11mm Rasp/Trial, 7°, 8mm, Short Stop
0019083703236414mm X 11mm Rasp/Trial, 7°, 7mm, Short Stop
0019083703235714mm X 11mm Rasp/Trial, 7°, 6mm, Short Stop
0019083703234014mm X 11mm Rasp/Trial, 7°, 5mm, Short Stop

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