Integrated Spine System

GUDID 00822409024438

Diameter 5.5 mm x 200 mm Straight Spinal Rod Ti

Ortho Development Corporation

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00822409024438
NIH Device Record Key95c7db27-f099-4b5b-8824-9cbd541d9995
Commercial Distribution Discontinuation2016-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIntegrated Spine System
Version Model Number158-0200
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Length200 Millimeter
Length200 Millimeter
Length200 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter
Outer Diameter5.5 Millimeter
Length200 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409024438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

[00822409024438]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [Integrated Spine System]

00822409031030Diameter 8.5 x 80 mm Pedicle Screw
00822409031023Diameter 8.5 x 55 mm Pedicle Screw
00822409031016Diameter 8.5 x 50 mm Pedicle Screw
00822409031009Diameter 8.5 x 45 mm Pedicle Screw
00822409030996Diameter 8.5 x 40 mm Pedicle Screw
00822409030989Diameter 8.5 x 35 mm Pedicle Screw
00822409030972Diameter 8.5 x 30 mm Pedicle Screw
00822409030965Diameter 8.5 x 25 mm Pedicle Screw
00822409030958Diameter 8.5 x 100 mm Pedicle Screw
00822409030941Diameter 7.5 x 80 mm Pedicle Screw
00822409030934Diameter 7.5 x 60 mm Pedicle Screw
00822409030927Diameter 7.5 x 55 mm Pedicle Screw
00822409030910Diameter 7.5 x 50 mm Pedicle Screw
00822409030903Diameter 7.5 x 45 mm Pedicle Screw
00822409030897Diameter 7.5 x 40 mm Pedicle Screw
00822409030880Diameter 7.5 x 35 mm Pedicle Screw
00822409030873Diameter 7.5 x 30 mm Pedicle Screw
00822409030866Diameter 7.5 x 25 mm Pedicle Screw
00822409030859Diameter 7.5 x 100 mm Pedicle Screw
00822409030842Transverse Connector, Extra Long
00822409030835Diameter 6.5 x 60 mm Pedicle Screw
00822409030828Diameter 6.5 x 55 mm Pedicle Screw
00822409030811Diameter 6.5 x 50 mm Pedicle Screw
00822409030804Diameter 6.5 x 45 mm Pedicle Screw
00822409030798Diameter 6.5 x 40 mm Pedicle Screw
00822409030781Diameter 6.5 x 35 mm Pedicle Screw
00822409030774Diameter 6.5 x 30 mm Pedicle Screw
00822409030767Diameter 6.5 x 25 mm Pedicle Screw
00822409030750Transverse Connector, Long
00822409030743Diameter 5.5 x 50 mm Pedicle Screw
00822409030736Diameter 5.5 x 45 mm Pedicle Screw
00822409030729Diameter 5.5 x 40 mm Pedicle Screw
00822409030712Diameter 5.5 x 35 mm Pedicle Screw
00822409030705Diameter 5.5 x 30 mm Pedicle Screw
00822409030699Diameter 5.5 x 25 mm Pedicle Screw
00822409030682Transverse Connector, Medium
00822409030675Cap and Set Screw
00822409030668Diameter 4.75 x 50 mm Pedicle Screw
00822409030651Diameter 4.75 x 45 mm Pedicle Screw
00822409030644Diameter 4.75 x 40 mm Pedicle Screw
00822409030637Diameter 4.75 x 35 mm Pedicle Screw
00822409030620Diameter 4.75 x 30 mm Pedicle Screw
00822409030613Diameter 4.75 x 25 mm Pedicle Screw
00822409030606Diameter 4.75 x 20 mm Pedicle Screw
00822409030590Transverse Connector, Short
00822409025121Diameter 5.5 mm x 500 mm Straight Spinal Rod
00822409025107Diameter 5.5 mm x 405 mm Straight Spinal Rod
00822409025084Diameter 5.5 mm x 200 mm Straight Spinal Rod
00822409025060Diameter 5.5 mm x 105 mm Straight Spinal Rod
00822409025046Diameter 5.5 mm x 90 mm Straight Spinal Rod
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.