ProLift Expandable Interbody, 10mm x 28mm, Large 12 degree

GUDID 00190837018993

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00190837018993
NIH Device Record Key1dd8768a-170b-4ef8-adac-97df00f04c5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProLift Expandable Interbody, 10mm x 28mm, Large 12 degree
Version Model Number58-1028-1210
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837018993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00190837018993]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-08

Devices Manufactured by Life Spine, Inc.

00190837169428 - TruLift 1-Hole Plate2024-03-28
00190837147327 - ProLift Lateral2024-03-21
00190837171674 - ProLift Lateral2024-03-21
00190837138974 - ProLift2024-02-08
00190837169411 - TruLift 2024-02-02
00190837116248 - Aileron2023-11-16
00190837168322 - ARx2023-11-16
00190837135393 - ARx2023-10-16

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