Threshold Set Screww/ Pedicle Screw 530-0007

GUDID M7405300007

Set Screw With Pedicle Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable
Primary Device IDM7405300007
NIH Device Record Key5ae0d5b8-17a0-4baa-a186-d780dfb55c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Set Screww/ Pedicle Screw
Version Model Number10-10-09-X
Catalog Number530-0007
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com
Phone+1(651)256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405300007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

[M7405300007]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2015-01-09

Devices Manufactured by SPINEOLOGY INC.

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M7401001341 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-11 Bevel Graft Tube
M7401001300 - Threshold V2 Pedicular Fixation System2025-07-10 Straight Lumbar Probe
M7401001301 - Threshold V2 Pedicular Fixation System2025-07-10 Curved Duckbill Probe
M7401001336 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Midline 4mm
M7401001338 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 TLIF Portal Anchor, Angled 4mm
M7401001339 - OptiMesh Multiplanar Expandable Interbody Fusion System2025-07-08 Modified Portal Stem
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