Pivot Bipolar

GUDID 00822409015429

28x58mm Bipolar

Ortho Development Corporation

Femoral head bipolar component Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 00822409015429
• NIH Device Record Key: 04ae14ba-75cb-486e-9a86-0fe278da4eae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pivot Bipolar
• Version Model Number: 133-2858
• 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

• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 58 Millimeter
• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409015429 [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