Threshold V2 Pedicular Fixation System 570-8555

GUDID M7405708555

Reduction Screw, Uncoated

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable
Primary Device IDM7405708555
NIH Device Record Keydee14430-cfac-46a1-b01c-0a07690487d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold V2 Pedicular Fixation System
Version Model Number10-10-84-9
Catalog Number570-8555
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)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com
Phone+1(651)259-8500
Emailinfo@spineology.com

Device Dimensions

Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0
Length55 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405708555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

[M7405708555]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-22
Device Publish Date2017-04-25

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