Threshold V2 Pedicular Fixation System 100-1300

GUDID M7401001300

Straight Lumbar Probe

SPINEOLOGY INC.

Orthopaedic prosthesis implantation positioning instrument, single-use
Primary Device IDM7401001300
NIH Device Record Key179ae53a-fd51-465a-93be-8ca6a35027c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold V2 Pedicular Fixation System
Version Model Number102-60-01
Catalog Number100-1300
Company DUNS033014361
Company NameSPINEOLOGY INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com
Phone651-256-8500
Emailinfo@spineology.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7401001300 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

[M7401001300]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

On-Brand Devices [Threshold V2 Pedicular Fixation System]

M7401001274Short Set Screw Driver
M7401000502Long Set Screw Driver
M7405708599Reduction Screw, Uncoated
M7405708590Reduction Screw, Uncoated
M7405708580Reduction Screw, Uncoated
M7405708570Reduction Screw, Uncoated
M7405708565Reduction Screw, Uncoated
M7405708560Reduction Screw, Uncoated
M7405708555Reduction Screw, Uncoated
M7405708550Reduction Screw, Uncoated
M7405708545Reduction Screw, Uncoated
M7405708540Reduction Screw, Uncoated
M7405708535Reduction Screw, Uncoated
M7405708530Reduction Screw, Uncoated
M7405707565Reduction Screw, Uncoated
M7405707560Reduction Screw, Uncoated
M7405707555Reduction Screw, Uncoated
M7405707550Reduction Screw, Uncoated
M7405707545Reduction Screw, Uncoated
M7405707540Reduction Screw, Uncoated
M7405707535Reduction Screw, Uncoated
M7405707530Reduction Screw, Uncoated
M7405706565Reduction Screw, Uncoated
M7405706560Reduction Screw, Uncoated
M7405706555Reduction Screw, Uncoated
M7405706550Reduction Screw, Uncoated
M7405706545Reduction Screw, Uncoated
M7405706540Reduction Screw, Uncoated
M7405706535Reduction Screw, Uncoated
M7405706530Reduction Screw, Uncoated
M7405705560Reduction Screw, Uncoated
M7405705555Reduction Screw, Uncoated
M7405705550Reduction Screw, Uncoated
M7405705545Reduction Screw, Uncoated
M7405705540Reduction Screw, Uncoated
M7405705535Reduction Screw, Uncoated
M7405705530Reduction Screw, Uncoated
M7405705050Reduction Screw, Uncoated
M7405705045Reduction Screw, Uncoated
M7405705040Reduction Screw, Uncoated
M7405705035Reduction Screw, Uncoated
M7405705030Reduction Screw, Uncoated
M7401001301Curved Duckbill Probe
M7401001300Straight Lumbar Probe
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