Pagoda

GUDID 00822409022991

Diameter 8.5 mm x 55 mm Polyaxial Screw

Ortho Development Corporation

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00822409022991
• NIH Device Record Key: 976c16fd-bbf5-4fa3-9c19-f96711f136cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pagoda
• Version Model Number: 752-8555-11A
• 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

Device Dimensions

• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409022991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131785

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [Pagoda]

• 00822409034222: Diameter 5.5 mm x 500 mm Straight Spinal Rod
• 00822409034215: Diameter 5.5 mm x 405 mm Straight Spinal Rod
• 00822409034208: Diameter 5.5 mm x 200 mm Straight Spinal Rod
• 00822409034192: Diameter 5.5 mm x 105 mm Straight Spinal Rod
• 00822409034185: Diameter 5.5 mm x 90 mm Straight Spinal Rod
• 00822409034178: Diameter 5.5 mm x 85 mm Straight Spinal Rod
• 00822409034161: Diameter 5.5 mm x 80 mm Straight Spinal Rod
• 00822409034154: Diameter 5.5 mm x 75 mm Straight Spinal Rod
• 00822409034147: Diameter 5.5 mm x 70 mm Straight Spinal Rod
• 00822409034130: Diameter 5.5 mm x 65 mm Straight Spinal Rod
• 00822409034123: Diameter 5.5 mm x 60 mm Straight Spinal Rod
• 00822409034116: Diameter 5.5 mm x 55 mm Straight Spinal Rod
• 00822409034109: Diameter 5.5 mm x 50 mm Straight Spinal Rod
• 00822409034093: Diameter 5.5 mm x 45 mm Straight Spinal Rod
• 00822409034086: Diameter 5.5 mm x 40 mm Straight Spinal Rod
• 00822409034079: Diameter 5.5 mm x 35 mm Straight Spinal Rod
• 00822409034062: Diameter 5.5 mm x 30 mm Straight Spinal Rod
• 00822409034055: Diameter 5.5 mm x 150 mm Curved Rod Ti,
• 00822409034048: Diameter 5.5 mm x 135 mm Curved Rod Ti
• 00822409034031: Diameter 5.5 mm x 120 mmCurved Rod Ti
• 00822409034024: Diameter 5.5 mm x 105 mm Curved Spinal Rod
• 00822409034017: Diameter 5.5 mm x 90 mm Curved Spinal Rod
• 00822409034000: Diameter 5.5 mm x 85 mm Curved Spinal Rod
• 00822409033997: Diameter 5.5 mm x 80 mm Curved Spinal Rod
• 00822409033980: Diameter 5.5 mm x 75 mm Curved Spinal Rod
• 00822409033973: Diameter 5.5 mm x 70 mm Curved Spinal Rod
• 00822409033966: Diameter 5.5 mm x 65 mm Curved Spinal Rod
• 00822409033959: Diameter 5.5 mm x 60 mm Curved Spinal Rod
• 00822409033942: Diameter 5.5 mm x 55 mm Curved Spinal Rod
• 00822409033935: Diameter 5.5 mm x 50 mm Curved Spinal Rod
• 00822409033928: Diameter 5.5 mm x 45 mm Curved Spinal Rod
• 00822409033911: Diameter 5.5 mm x 40 mm Curved Spinal Rod
• 00822409033904: Diameter 5.5 mm x 35 mm Curved Spinal Rod
• 00822409033898: Diameter 5.5 mm x 30 mm Curved Spinal Rod
• 00822409029938: Diameter 8.5 mm x 90 mm Monoaxial Screw
• 00822409029921: Diameter 8.5 mm x 80 mm Monoaxial Screw
• 00822409029914: Diameter 8.5 mm x 70 mm Monoaxial Screw
• 00822409029891: Diameter 8.5 mm x 60 mm Monoaxial Screw
• 00822409029860: Diameter 8.5 mm x 60 mm Polyaxial Reduction Screw
• 00822409029853: Diameter 8.5 mm x 60 mm Polyaxial Screw
• 00822409029839: Diameter 8.5 mm x 55 mm Monoaxial Screw
• 00822409029808: Diameter 8.5 mm x 55 mm Polyaxial Reduction Screw
• 00822409029792: Diameter 8.5 mm x 55 mm Polyaxial Screw
• 00822409029778: Diameter 8.5 mm x 50 mm Monoaxial Screw
• 00822409029747: Diameter 8.5 mm x 50 mm Polyaxial Reduction Screw
• 00822409029730: Diameter 8.5 mm x 50 mm Polyaxial Screw
• 00822409029716: Diameter 8.5 mm x 45 mm Monoaxial Screw
• 00822409029686: Diameter 8.5 mm x 45 mm Polyaxial Reduction Screw
• 00822409029679: Diameter 8.5 mm x 45 mm Polyaxial Screw
• 00822409029655: Diameter 8.5 mm x 40 mm Monoaxial Screw