CoreLink Foundation 3D Stand Alone Screw

GUDID M7251045520

Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 20mm

CORELINK LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM7251045520
NIH Device Record Key07ab8ef9-1ce1-424e-a518-816fb1e4c914
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoreLink Foundation 3D Stand Alone Screw
Version Model Number10455-20
Company DUNS064191453
Company NameCORELINK LLC
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7251045520 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

[M7251045520]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-23
Device Publish Date2024-08-15

On-Brand Devices [CoreLink Foundation 3D Stand Alone Screw]

M7251056530Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 30mm
M7251056525Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 25mm
M7251056520Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 20mm
M7251056515Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 6.5mm x 15mm
M7251055530Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 30mm
M7251055525Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 25mm
M7251055515Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 15mm
M7251046530Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 30mm
M7251046525Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 25mm
M7251046520Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 20mm
M7251046515Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 6.5mm x 15mm
M7251045530Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 30mm
M7251045525Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 25mm
M7251045520Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 20mm
M7251045515Foundation 3D Stand Alone Screw-ALIF, Fixed Self Drilling, 5.5mm x 15mm
M7251036530Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 30mm
M7251036525Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 25mm
M7251036520Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 20mm
M7251036515Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 6.5mm x 15mm
M7251035530Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 30mm
M7251035525Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 25mm
M7251035520Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 20mm
M7251035515Foundation 3D Stand Alone Screw-ALIF, Variable Self Tapping, 5.5mm x 15mm
M7251026530Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 30mm
M7251026525Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 25mm
M7251026520Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 20mm
M7251026515Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 6.5mm x 15mm
M7251025530Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 30mm
M7251025525Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 25mm
M7251025520Foundation 3D Stand Alone Screw-ALIF, Variable Self Drilling, 5.5mm x 20mm
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