Biolox Delta

GUDID 00822409015795

36mm +2

Ortho Development Corporation

Coated hip femur prosthesis, modular

• Primary Device ID: 00822409015795
• NIH Device Record Key: fe316370-0d1c-4bb6-b3c7-2f2fb390213e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta
• Version Model Number: 136-3603
• 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

• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409015795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111936

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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: 2015-08-31

On-Brand Devices [Biolox Delta]

• 00822409015870: 40mm +6
• 00822409015863: 40mm +2
• 00822409015856: 40mm -1
• 00822409015849: 40mm -5
• 00822409015801: 36mm +6
• 00822409015795: 36mm +2
• 00822409015788: 36mm -1
• 00822409015771: 36mm -5
• 00822409015733: 32mm +6
• 00822409015726: 32mm +2
• 00822409015719: 32mm -1
• 00822409015702: 32mm -5
• 00822409015665: 28mm +2
• 00822409015658: 28mm -1
• 00822409015641: 28mm -5