Dyna-Link Elite

GUDID 00190837020750

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837020750
NIH Device Record Keya1b69a15-ce97-4ce1-ae7a-4aae7bcd75b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna-Link Elite
Version Model Number81-155-20
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
GS100190837020750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837020750]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-05-24

On-Brand Devices [Dyna-Link Elite]

0019083702100981-3828-1217
0019083702099681-3828-1215
0019083702098981-3828-1213
0019083702097281-3828-1211
0019083702096581-3828-0617
0019083702095881-3828-0615
0019083702094181-3828-0613
0019083702093481-3828-0611
0019083702092781-3424-1217
0019083702091081-3424-1215
0019083702090381-3424-1213
0019083702089781-3424-1211
0019083702088081-3424-0617
0019083702087381-3424-0615
0019083702086681-3424-0613
0019083702085981-3424-0611
0019083702084281-160-30
0019083702083581-160-27
0019083702082881-160-25
0019083702081181-160-22
0019083702080481-160-20
0019083702079881-155-30
0019083702078181-155-27
0019083702077481-155-25
0019083702076781-155-22
0019083702075081-155-20
00190837071240Dyna-Link, 42mmx30mmx17mm, 12 Degree
00190837071233Dyna-Link, 34mmx24mmx13mm, 12 Degree
00190837034696Dyna-Link Elite Graft Packing Plate, 38x28

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