Solitude Unipolar

GUDID 00822409015009

58mm Unipolar

Ortho Development Corporation

Femoral head/stem prosthesis adaptor

• Primary Device ID: 00822409015009
• NIH Device Record Key: 9cd861b5-eb5d-4d3c-971e-1e5be8647f04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitude Unipolar
• Version Model Number: 132-0058
• 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

Device Dimensions

• Outer Diameter: 58 Millimeter
• Outer Diameter: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409015009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042973

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

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 [Solitude Unipolar]

• 00822409015078: -3mm 12/14 Offset Adapter
• 00822409015061: +9mm 12/14 Offset Adapter
• 00822409015054: +6mm 12/14 Offset Adapter
• 00822409015047: +3mm 12/14 Offset Adapter
• 00822409015030: +0mm 12/14 Offset Adapter
• 00822409015023: 60mm Unipolar
• 00822409015016: 59mm Unipolar
• 00822409015009: 58mm Unipolar
• 00822409014996: 57mm Unipolar
• 00822409014989: 56mm Unipolar
• 00822409014972: 55mm Unipolar
• 00822409014965: 54mm Unipolar
• 00822409014958: 53mm Unipolar
• 00822409014941: 52mm Unipolar
• 00822409014934: 51mm Unipolar
• 00822409014927: 50mm Unipolar
• 00822409014910: 49mm Unipolar
• 00822409014903: 48mm Unipolar
• 00822409014897: 47mm Unipolar
• 00822409014880: 46mm Unipolar
• 00822409014873: 45mm Unipolar
• 00822409014866: 44mm Unipolar
• 00822409014859: 43mm Unipolar
• 00822409014842: 42mm Unipolar
• 00822409014835: 41mm Unipolar
• 00822409014828: 40mm Unipolar
• 00822409014811: 39mm Unipolar
• 00822409014804: 38mm Unipolar