Threshold Set Screw 530-0001

GUDID M7405300001

Set Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable
Primary Device IDM7405300001
NIH Device Record Key16b770c7-c8db-4884-946a-f8d2b821e39e
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Set Screw
Version Model Number10-10-12
Catalog Number530-0001
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCM7405300001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

Device Entry Metadata

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

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