Integrated Spine System

GUDID 00822409024902

Diameter 5.5 mm x 55 mm Straight Spinal Rod

Ortho Development Corporation

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00822409024902
• NIH Device Record Key: 5d0d28af-2107-44b0-b7dd-520b4758d44b
• Commercial Distribution Discontinuation: 2016-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integrated Spine System
• Version Model Number: 158-3055
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409024902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061524

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

[00822409024902]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Integrated Spine System]

• 00822409031030: Diameter 8.5 x 80 mm Pedicle Screw
• 00822409031023: Diameter 8.5 x 55 mm Pedicle Screw
• 00822409031016: Diameter 8.5 x 50 mm Pedicle Screw
• 00822409031009: Diameter 8.5 x 45 mm Pedicle Screw
• 00822409030996: Diameter 8.5 x 40 mm Pedicle Screw
• 00822409030989: Diameter 8.5 x 35 mm Pedicle Screw
• 00822409030972: Diameter 8.5 x 30 mm Pedicle Screw
• 00822409030965: Diameter 8.5 x 25 mm Pedicle Screw
• 00822409030958: Diameter 8.5 x 100 mm Pedicle Screw
• 00822409030941: Diameter 7.5 x 80 mm Pedicle Screw
• 00822409030934: Diameter 7.5 x 60 mm Pedicle Screw
• 00822409030927: Diameter 7.5 x 55 mm Pedicle Screw
• 00822409030910: Diameter 7.5 x 50 mm Pedicle Screw
• 00822409030903: Diameter 7.5 x 45 mm Pedicle Screw
• 00822409030897: Diameter 7.5 x 40 mm Pedicle Screw
• 00822409030880: Diameter 7.5 x 35 mm Pedicle Screw
• 00822409030873: Diameter 7.5 x 30 mm Pedicle Screw
• 00822409030866: Diameter 7.5 x 25 mm Pedicle Screw
• 00822409030859: Diameter 7.5 x 100 mm Pedicle Screw
• 00822409030842: Transverse Connector, Extra Long
• 00822409030835: Diameter 6.5 x 60 mm Pedicle Screw
• 00822409030828: Diameter 6.5 x 55 mm Pedicle Screw
• 00822409030811: Diameter 6.5 x 50 mm Pedicle Screw
• 00822409030804: Diameter 6.5 x 45 mm Pedicle Screw
• 00822409030798: Diameter 6.5 x 40 mm Pedicle Screw
• 00822409030781: Diameter 6.5 x 35 mm Pedicle Screw
• 00822409030774: Diameter 6.5 x 30 mm Pedicle Screw
• 00822409030767: Diameter 6.5 x 25 mm Pedicle Screw
• 00822409030750: Transverse Connector, Long
• 00822409030743: Diameter 5.5 x 50 mm Pedicle Screw
• 00822409030736: Diameter 5.5 x 45 mm Pedicle Screw
• 00822409030729: Diameter 5.5 x 40 mm Pedicle Screw
• 00822409030712: Diameter 5.5 x 35 mm Pedicle Screw
• 00822409030705: Diameter 5.5 x 30 mm Pedicle Screw
• 00822409030699: Diameter 5.5 x 25 mm Pedicle Screw
• 00822409030682: Transverse Connector, Medium
• 00822409030675: Cap and Set Screw
• 00822409030668: Diameter 4.75 x 50 mm Pedicle Screw
• 00822409030651: Diameter 4.75 x 45 mm Pedicle Screw
• 00822409030644: Diameter 4.75 x 40 mm Pedicle Screw
• 00822409030637: Diameter 4.75 x 35 mm Pedicle Screw
• 00822409030620: Diameter 4.75 x 30 mm Pedicle Screw
• 00822409030613: Diameter 4.75 x 25 mm Pedicle Screw
• 00822409030606: Diameter 4.75 x 20 mm Pedicle Screw
• 00822409030590: Transverse Connector, Short
• 00822409025121: Diameter 5.5 mm x 500 mm Straight Spinal Rod
• 00822409025107: Diameter 5.5 mm x 405 mm Straight Spinal Rod
• 00822409025084: Diameter 5.5 mm x 200 mm Straight Spinal Rod
• 00822409025060: Diameter 5.5 mm x 105 mm Straight Spinal Rod
• 00822409025046: Diameter 5.5 mm x 90 mm Straight Spinal Rod