Threshold Fixed Perc Rod 530-4095

GUDID M7405304095

Fixed Perc Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod
Primary Device IDM7405304095
NIH Device Record Key3b87a58a-5bdc-49df-bf2b-3de41e57c715
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Fixed Perc Rod
Version Model Number10-10-08-3
Catalog Number530-4095
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

Device Dimensions

Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter
Device Size Text, specify0
Length95 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405304095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

[M7405304095]

Ethylene Oxide

Device Entry Metadata

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

On-Brand Devices [Threshold Fixed Perc Rod]

M7405304120Fixed Perc Rod
M7405304110Fixed Perc Rod
M7405304100Fixed Perc Rod
M7405304095Fixed Perc Rod
M7405304090Fixed Perc Rod
M7405304085Fixed Perc Rod
M7405304080Fixed Perc Rod
M7405304075Fixed Perc Rod
M7405304070Fixed Perc Rod
M7405304065Fixed Perc Rod
M7405304060Fixed Perc Rod
M7405304055Fixed Perc Rod
M7405304050Fixed Perc Rod
M7405304045Fixed Perc Rod
M7405304040Fixed Perc Rod
M7405304035Fixed Perc Rod
M7405304030Fixed Perc Rod
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.