Dyna-Link Stand-Alone Anterior Lumbar System 125-172

GUDID 00190837041793

Cover Plate Locking Driver

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837041793
NIH Device Record Key51ee1cd9-1c20-4511-98a5-d7fb0acc7190
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna-Link Stand-Alone Anterior Lumbar System
Version Model Number125-172
Catalog Number125-172
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
GS100190837041793 [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

[00190837041793]

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 [Dyna-Link Stand-Alone Anterior Lumbar System]

0019083700371580-255-30
0019083700370880-255-25
0019083700369280-255-20
0019083700368580-620
0019083700367880-3830-1217
0019083700366180-3830-1215
0019083700365480-3830-1213
0019083700364780-3830-1211
0019083700363080-3830-0617
0019083700362380-3830-0615
0019083700361680-3830-0613
0019083700360980-3830-0611
0019083700359380-3226-1217
0019083700358680-3226-1215
0019083700357980-3226-1213
0019083700356280-3226-1211
0019083700355580-3226-0617
0019083700354880-3226-0615
0019083700353180-3226-0613
0019083700352480-3226-0611
0019083700351780-155-30
0019083700350080-155-25
0019083700349480-155-20
00190837042660Centering Bent Awl, Long
00190837042653Angulating Drill, Short Tip
00190837042646Angulating Drill, Short
00190837042639Angulating Awl, Short
001908370430015.5mm Fixed Screw, 30mm
001908370429985.5mm Fixed Screw, 27mm
001908370429815.5mm Fixed Screw, 25mm
001908370429745.5mm Fixed Screw, 22mm
001908370429675.5mm Fixed Screw, 20mm
00190837042950Dyna-Link, 31mmx24mmx11mm, 12 Degree
00190837042943Dyna-Link Assy, Lock Plate Assembly
001908370429365.5mm Variable Screw, 35mm Length
001908370429295.5mm Variable Screw, 30mm Length
001908370429125.5mm Variable Screw, 25mm Length
001908370429055.5mm Variable Screw, 20mm Length
00190837042899Stand Alone Spacer Assy, 34mmx28mmx13mm, 6 Degree
00190837042882Stand Alone Spacer Assy, 34mmx28mmx11mm, 6 Degree
00190837042875Stand Alone Spacer Assy, 34mmx28mmx15mm, 12 Degree
00190837042868Stand Alone Spacer Assy, 34mmx28mmx11mm, 12 Degree
00190837042851Dyna-Link Screw Caddy 20-35mm
00190837042844Dyna-Link Implant Caddy 42mm x 30mm
00190837042837Dyna-Link Screw Caddy
00190837042820Dyna-Link Implant Caddy 38mm x 30mm
00190837042813Dyna-Link Implant Caddy 32mm x 26mm
00190837042806Dyna-Link Implant Caddy, 34mm X 28mm
00190837042790Dyna-Link Screw Caddy
00190837042783Dyna-Link Screw Caddy

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