ProLift Expandable Spacer

GUDID 00190837021665

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00190837021665
NIH Device Record Keyb578e91d-c446-4297-971d-2640bbba3ff2
Commercial Distribution StatusIn Commercial Distribution
Brand NameProLift Expandable Spacer
Version Model Number58-1228-1510D
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837021665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-14

On-Brand Devices [ProLift Expandable Spacer]

0019083702166558-1228-1510D
0019083702165858-1228-1508P
0019083702164158-1228-1508D
0019083702163458-1228-1210D
0019083702162758-1228-1208P

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