Pivot Bipolar

GUDID 00822409015412

28x57mm Bipolar

Ortho Development Corporation

Femoral head bipolar component

• Primary Device ID: 00822409015412
• NIH Device Record Key: f4e8337b-fbdb-426c-8d63-0557bae9ce06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pivot Bipolar
• Version Model Number: 133-2857
• 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

Device Dimensions

• Outer Diameter: 57 Millimeter
• Outer Diameter: 57 Millimeter
• Outer Diameter: 57 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 57 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409015412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050966

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2015-08-31

On-Brand Devices [Pivot Bipolar]

• 00822409015443: 28x60mm Bipolar
• 00822409015436: 28x59mm Bipolar
• 00822409015429: 28x58mm Bipolar
• 00822409015412: 28x57mm Bipolar
• 00822409015405: 28x56mm Bipolar
• 00822409015399: 28x55mm Bipolar
• 00822409015382: 28x54mm Bipolar
• 00822409015375: 28x53mm Bipolar
• 00822409015368: 28x52mm Bipolar
• 00822409015351: 28x51mm Bipolar
• 00822409015344: 28x50mm Bipolar
• 00822409015337: 28x49mm Bipolar
• 00822409015320: 28x48mm Bipolar
• 00822409015313: 28x47mm Bipolar
• 00822409015306: 28x46mm Bipolar
• 00822409015290: 22x60mm Bipolar
• 00822409015283: 22x59mm Bipolar
• 00822409015276: 22x58mm Bipolar
• 00822409015269: 22x57mm Bipolar
• 00822409015252: 22x56mm Bipolar
• 00822409015245: 22x55mm Bipolar
• 00822409015238: 22x54mm Bipolar
• 00822409015221: 22x53mm Bipolar
• 00822409015214: 22x52mm Bipolar
• 00822409015207: 22x51mm Bipolar
• 00822409015191: 22x50mm Bipolar
• 00822409015184: 22x49mm Bipolar
• 00822409015177: 22x48mm Bipolar
• 00822409015160: 22x47mm Bipolar
• 00822409015153: 22x46mm Bipolar
• 00822409015146: 22x45mm Bipolar
• 00822409015139: 22x44mm Bipolar
• 00822409015122: 22x43mm Bipolar
• 00822409015115: 22x42mm Bipolar
• 00822409015108: 22x41mm Bipolar
• 00822409015092: 22x39mm Bipolar
• 00822409015085: 22x38mm Bipolar
• 00822409010226: 22x40mm Bipolar