Dyna-Link Stand-Alone Anterior Lumbar System 125-202

GUDID 00190837041892

Dyna-Link Hex Driver Shaft with Screw Lock

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837041892
• NIH Device Record Key: c23a8dec-ce72-4c1a-9fd0-ef239bad10db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna-Link Stand-Alone Anterior Lumbar System
• Version Model Number: 125-202
• Catalog Number: 125-202
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837041892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091301

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190837041892]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Dyna-Link Stand-Alone Anterior Lumbar System]

• 00190837003715: 80-255-30
• 00190837003708: 80-255-25
• 00190837003692: 80-255-20
• 00190837003685: 80-620
• 00190837003678: 80-3830-1217
• 00190837003661: 80-3830-1215
• 00190837003654: 80-3830-1213
• 00190837003647: 80-3830-1211
• 00190837003630: 80-3830-0617
• 00190837003623: 80-3830-0615
• 00190837003616: 80-3830-0613
• 00190837003609: 80-3830-0611
• 00190837003593: 80-3226-1217
• 00190837003586: 80-3226-1215
• 00190837003579: 80-3226-1213
• 00190837003562: 80-3226-1211
• 00190837003555: 80-3226-0617
• 00190837003548: 80-3226-0615
• 00190837003531: 80-3226-0613
• 00190837003524: 80-3226-0611
• 00190837003517: 80-155-30
• 00190837003500: 80-155-25
• 00190837003494: 80-155-20
• 00190837042660: Centering Bent Awl, Long
• 00190837042653: Angulating Drill, Short Tip
• 00190837042646: Angulating Drill, Short
• 00190837042639: Angulating Awl, Short
• 00190837043001: 5.5mm Fixed Screw, 30mm
• 00190837042998: 5.5mm Fixed Screw, 27mm
• 00190837042981: 5.5mm Fixed Screw, 25mm
• 00190837042974: 5.5mm Fixed Screw, 22mm
• 00190837042967: 5.5mm Fixed Screw, 20mm
• 00190837042950: Dyna-Link, 31mmx24mmx11mm, 12 Degree
• 00190837042943: Dyna-Link Assy, Lock Plate Assembly
• 00190837042936: 5.5mm Variable Screw, 35mm Length
• 00190837042929: 5.5mm Variable Screw, 30mm Length
• 00190837042912: 5.5mm Variable Screw, 25mm Length
• 00190837042905: 5.5mm Variable Screw, 20mm Length
• 00190837042899: Stand Alone Spacer Assy, 34mmx28mmx13mm, 6 Degree
• 00190837042882: Stand Alone Spacer Assy, 34mmx28mmx11mm, 6 Degree
• 00190837042875: Stand Alone Spacer Assy, 34mmx28mmx15mm, 12 Degree
• 00190837042868: Stand Alone Spacer Assy, 34mmx28mmx11mm, 12 Degree
• 00190837042851: Dyna-Link Screw Caddy 20-35mm
• 00190837042844: Dyna-Link Implant Caddy 42mm x 30mm
• 00190837042837: Dyna-Link Screw Caddy
• 00190837042820: Dyna-Link Implant Caddy 38mm x 30mm
• 00190837042813: Dyna-Link Implant Caddy 32mm x 26mm
• 00190837042806: Dyna-Link Implant Caddy, 34mm X 28mm
• 00190837042790: Dyna-Link Screw Caddy
• 00190837042783: Dyna-Link Screw Caddy