PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree 52-1028-18

GUDID 00190837026349

PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree

Life Spine, Inc.

Polymeric spinal fusion cage, non-sterile
Primary Device ID00190837026349
NIH Device Record Key927dc99a-3a2c-4139-a548-5527ae7fac28
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree
Version Model Number52-1028-18
Catalog Number52-1028-18
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
GS100190837026349 [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

[00190837026349]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by Life Spine, Inc.

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00190837026349 - PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree2019-11-27PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree
00190837026349 - PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree2019-11-27 PLATEAU Interbody, Straight, Bulleted, 10mm 28mm x 18mm, 0 Degree
00190837066123 - ProLift Expandable Spacer System2019-11-27 Expandable Cage Installer, Driver
00190837066154 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 6mm
00190837066192 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 10mm
00190837066208 - ProLift Expandable Spacer System2019-11-27 Paddle Distractor / Shaver, 11mm
00190837079239 - General Manual Instrument2019-11-27 T30 Driver
00190837081997 - Nautilus2019-11-27 Torque Limit 1/4 Inch Sq T-Handle, 80in-lb

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