Pisces Spinal System

GUDID 00822409043422

Modular 20mm Reduction Tulip Assembly 5.5mm

Ortho Development Corporation

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00822409043422
• NIH Device Record Key: 55c547f5-73fc-4e84-b07f-34979fa45ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pisces Spinal System
• Version Model Number: 753-0552
• 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: false
• Expiration Date: true
• 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
• 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
• 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

• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409043422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203023

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Pisces Spinal System]

• 00822409113248: Modular Solid DL Pedicle Screw Diameter 8.5x80mm
• 00822409113231: Modular Solid DL Pedicle Screw Diameter 8.5x75mm
• 00822409113224: Modular Solid DL Pedicle Screw Diameter 8.5x70mm
• 00822409113217: Modular Solid DL Pedicle Screw Diameter 8.5x65mm
• 00822409113200: Modular Solid DL Pedicle Screw Diameter 8.5x60mm
• 00822409113194: Modular Solid DL Pedicle Screw Diameter 8.5x55mm
• 00822409113187: Modular Solid DL Pedicle Screw Diameter 8.5x50mm
• 00822409113170: Modular Solid DL Pedicle Screw Diameter 8.5x45mm
• 00822409113163: Modular Solid DL Pedicle Screw Diameter 8.5x40mm
• 00822409113156: Modular Solid DL Pedicle Screw Diameter 8.5x35mm
• 00822409113149: Modular Solid DL Pedicle Screw Diameter 8.5x30mm
• 00822409113132: Modular Solid DL Pedicle Screw Diameter 7.5x60mm
• 00822409113125: Modular Solid DL Pedicle Screw Diameter 7.5x55mm
• 00822409113118: Modular Solid DL Pedicle Screw Diameter 7.5x50mm
• 00822409113101: Modular Solid DL Pedicle Screw Diameter 7.5x45mm
• 00822409113095: Modular Solid DL Pedicle Screw Diameter 7.5x40mm
• 00822409113088: Modular Solid DL Pedicle Screw Diameter 7.5x35mm
• 00822409113071: Modular Solid DL Pedicle Screw Diameter 7.5x30mm
• 00822409113064: Modular Solid DL Pedicle Screw Diameter 6.5x60mm
• 00822409113057: Modular Solid DL Pedicle Screw Diameter 6.5x55mm
• 00822409113040: Modular Solid DL Pedicle Screw Diameter 6.5x50mm
• 00822409113033: Modular Solid DL Pedicle Screw Diameter 6.5x45mm
• 00822409113026: Modular Solid DL Pedicle Screw Diameter 6.5x40mm
• 00822409113019: Modular Solid DL Pedicle Screw Diameter 6.5x35mm
• 00822409113002: Modular Solid DL Pedicle Screw Diameter 6.5x30mm
• 00822409112999: Modular Solid DL Pedicle Screw Diameter 6.5x25mm
• 00822409112982: Modular Solid DL Pedicle Screw Diameter 5.5x60mm
• 00822409112975: Modular Solid DL Pedicle Screw Diameter 5.5x55mm
• 00822409112968: Modular Solid DL Pedicle Screw Diameter 5.5x50mm
• 00822409112951: Modular Solid DL Pedicle Screw Diameter 5.5x45mm
• 00822409112944: Modular Solid DL Pedicle Screw Diameter 5.5x40mm
• 00822409112937: Modular Solid DL Pedicle Screw Diameter 5.5x35mm
• 00822409112920: Modular Solid DL Pedicle Screw Diameter 5.5x30mm
• 00822409112913: Modular Solid DL Pedicle Screw Diameter 5.5x25mm
• 00822409112906: Modular Solid DL Pedicle Screw Diameter 4.5x50mm
• 00822409112890: Modular Solid DL Pedicle Screw Diameter 4.5x45mm
• 00822409112883: Modular Solid DL Pedicle Screw Diameter 4.5x40mm
• 00822409112876: Modular Solid DL Pedicle Screw Diameter 4.5x35mm
• 00822409112869: Modular Solid DL Pedicle Screw Diameter 4.5x30mm
• 00822409112852: Modular Solid DL Pedicle Screw Diameter 4.5x25mm
• 00822409044269: Modular Cannulated DL Pedicle Screw Diameter 8.5x80mm
• 00822409044245: Modular Cannulated DL Pedicle Screw Diameter 8.5x75mm
• 00822409044221: Modular Cannulated DL Pedicle Screw Diameter 8.5x70mm
• 00822409044207: Modular Cannulated DL Pedicle Screw Diameter 8.5x65mm
• 00822409044184: Modular Cannulated DL Pedicle Screw Diameter 8.5x60mm
• 00822409044160: Modular Cannulated DL Pedicle Screw Diameter 8.5x55mm
• 00822409044146: Modular Cannulated DL Pedicle Screw Diameter 8.5x50mm
• 00822409044122: Modular Cannulated DL Pedicle Screw Diameter 8.5x45mm
• 00822409044108: Modular Cannulated DL Pedicle Screw Diameter 8.5x40mm
• 00822409044085: Modular Cannulated DL Pedicle Screw Diameter 8.5x35mm