Alpine Hip System

GUDID 00822409000081

STD Size 16 Stem Press-Fit

Ortho Development Corporation

Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular

• Primary Device ID: 00822409000081
• NIH Device Record Key: 179e79e4-7ad6-47ee-9082-21b1e2981e11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpine Hip System
• Version Model Number: 700-0016
• 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	00822409000081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141001

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 [Alpine Hip System]

• 00822409000258: EXT Size 20 Stem Press-Fit
• 00822409000241: EXT Size 19 Stem Press-Fit
• 00822409000234: EXT Size 18 Stem Press-Fit
• 00822409000227: EXT Size 17 Stem Press-Fit
• 00822409000210: EXT Size 16 Stem Press-Fit
• 00822409000203: EXT Size 15 Stem Press-Fit
• 00822409000197: EXT Size 14 Stem Press-Fit
• 00822409000180: EXT Size 13 Stem Press-Fit
• 00822409000173: EXT Size 12 Stem Press-Fit
• 00822409000166: EXT Size 11 Stem Press-Fit
• 00822409000159: EXT Size 10 Stem Press-Fit
• 00822409000142: EXT Size 9 Stem Press-Fit
• 00822409000128: STD Size 20 Stem Press-Fit
• 00822409000111: STD Size 19 Stem Press-Fit
• 00822409000104: STD Size 18 Stem Press-Fit
• 00822409000098: STD Size 17 Stem Press-Fit
• 00822409000081: STD Size 16 Stem Press-Fit
• 00822409000074: STD Size 15 Stem Press-Fit
• 00822409000067: STD Size 14 Stem Press-Fit
• 00822409000050: STD Size 13 Stem Press-Fit
• 00822409000043: STD Size 12 Stem Press-Fit
• 00822409000036: STD Size 11 Stem Press-Fit
• 00822409000029: STD Size 10 Stem Press-Fit
• 00822409000012: STD Size 9 Stem Press-Fit