Primary Device ID | M7251036520 |
NIH Device Record Key | 0c81f60a-bc35-4e31-aba9-d3487d7ad47a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoreLink Foundation 3D Stand Alone Screw |
Version Model Number | 10365-20 |
Company DUNS | 064191453 |
Company Name | CORELINK LLC |
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 | true |
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 |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com | |
Phone | 6019191119 |
info@zavation.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M7251036520 [Primary] |
OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
[M7251036520]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-23 |
Device Publish Date | 2024-08-15 |
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M7251056525 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 25mm |
M7251056520 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 20mm |
M7251056515 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 15mm |
M7251055530 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 30mm |
M7251055525 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 25mm |
M7251055515 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 15mm |
M7251046530 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 30mm |
M7251046525 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 25mm |
M7251046520 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 20mm |
M7251046515 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 15mm |
M7251045530 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 30mm |
M7251045525 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 25mm |
M7251045520 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 20mm |
M7251045515 | Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 15mm |
M7251036530 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 30mm |
M7251036525 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 25mm |
M7251036520 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 20mm |
M7251036515 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 15mm |
M7251035530 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 30mm |
M7251035525 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 25mm |
M7251035520 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 20mm |
M7251035515 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 15mm |
M7251026530 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 30mm |
M7251026525 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 25mm |
M7251026520 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 20mm |
M7251026515 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 15mm |
M7251025530 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 30mm |
M7251025525 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 25mm |
M7251025520 | Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 20mm |