12/14 CoCr Femoral Head

GUDID 00822409016488

40mm, -3mm

Ortho Development Corporation

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 00822409016488
• NIH Device Record Key: 8b87e8b2-2b14-48e5-8e6d-4eee9e0d3456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12/14 CoCr Femoral Head
• Version Model Number: 138-4030
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00822409016488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042565

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 2017-01-17

On-Brand Devices [12/14 CoCr Femoral Head]

• 00822409016495: 40mm, -6mm
• 00822409016488: 40mm, -3mm
• 00822409016471: 40mm, +9mm
• 00822409016464: 40mm, +6mm
• 00822409016457: 40mm, +3mm
• 00822409016440: 40mm, +0mm