Threshold V2 Reduction Screw 571-7599

GUDID M7405717599

Reduction Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable
Primary Device IDM7405717599
NIH Device Record Key924f57f6-5de6-469e-8970-152d7b38ffb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold V2 Reduction Screw
Version Model Number10-10-80-100
Catalog Number571-7599
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 Dimensions

Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405717599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


[M7405717599]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-22
Device Publish Date2017-09-21

On-Brand Devices [Threshold V2 Reduction Screw]

M7405717599Reduction Screw
M7405717590Reduction Screw
M7405717580Reduction Screw
M7405717570Reduction Screw
M7405707599Reduction Screw
M7405707590Reduction Screw
M7405707580Reduction Screw
M7405707570Reduction Screw
M7405704550Reduction Screw
M7405704545Reduction Screw
M7405704540Reduction Screw
M7405704535Reduction Screw
M7405704530Reduction Screw
M7405704525Reduction Screw

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.