Threshold Solid Pedicle Screw 550-6555

GUDID M7405506555

Pedicle Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable
Primary Device IDM7405506555
NIH Device Record Key25780c24-413e-4910-a3fd-dac2735d787c
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreshold Solid Pedicle Screw
Version Model Number10-10-78-18
Catalog Number550-6555
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

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
HIBCCM7405506555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

[M7405506555]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2016-08-03

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