Delta Ceramic Femoral Head

GUDID 00822409034819

Femoral Head 32-12/14+0

Ortho Development Corporation

Coated hip femur prosthesis, modular Coated hip femur prosthesis, modular

• Primary Device ID: 00822409034819
• NIH Device Record Key: 90b614ac-21ba-4ca2-a785-701b9f050930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Ceramic Femoral Head
• Version Model Number: 136-3200
• 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: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409034819 [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: 2016-08-16

On-Brand Devices [Delta Ceramic Femoral Head]

• 00822409034963: Femoral Head 40-12/14-6
• 00822409034956: Femoral Head 40-12/14-3
• 00822409034949: Femoral Head 40-12/14+9
• 00822409034932: Femoral Head 40-12/14+6
• 00822409034925: Femoral Head 40-12/14+3
• 00822409034918: Femoral Head 40-12/14+0
• 00822409034901: Femoral Head 36-12/14-6
• 00822409034895: Femoral Head 36-12/14-3
• 00822409034888: Femoral Head 36-12/14+6
• 00822409034871: Femoral Head 36-12/14+3
• 00822409034864: Femoral Head 36-12/14+0
• 00822409034857: Femoral Head 32-12/14-6
• 00822409034840: Femoral Head 32-12/14-3
• 00822409034833: Femoral Head 32-12/14+6
• 00822409034826: Femoral Head 32-12/14+3
• 00822409034819: Femoral Head 32-12/14+0
• 00822409034802: Femoral Head 28-12/14-3
• 00822409034796: Femoral Head 28-12/14+3
• 00822409034789: Femoral Head 28-12/14+0