Threshold Articulating Perc Rod 530-6065

GUDID M7405306065

Articulating Perc Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod
Primary Device IDM7405306065
NIH Device Record Keyd82fa1af-e819-435a-abf5-7b9870d3adfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Articulating Perc Rod
Version Model Number10-10-07-19
Catalog Number530-6065
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

Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0
Length65 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405306065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

Ethylene Oxide

[M7405306065]

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 Articulating Perc Rod]

M7405306120Articulating Perc Rod
M7405306110Articulating Perc Rod
M7405306100Articulating Perc Rod
M7405306095Articulating Perc Rod
M7405306090Articulating Perc Rod
M7405306085Articulating Perc Rod
M7405306080Articulating Perc Rod
M7405306075Articulating Perc Rod
M7405306070Articulating Perc Rod
M7405306065Articulating Perc Rod
M7405306060Articulating Perc Rod
M7405306055Articulating Perc Rod
M7405306050Articulating Perc Rod
M7405306045Articulating Perc Rod
M7405306040Articulating Perc Rod
M7405306035Articulating Perc Rod
M7405306030Articulating Perc Rod
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.