Alpine

GUDID 00822409000401

Alpine Cemented Stem 11 EXT

Ortho Development Corporation

Metal-on-polyethylene total hip prosthesis Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 00822409000401
• NIH Device Record Key: f5b626e3-7f09-4d02-a65d-2105d553f0ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpine
• Version Model Number: 700-1211
• 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	00822409000401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153216

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: 2016-05-11

On-Brand Devices [Alpine]

• 00822409037049: Cemented Stem 16 EXT
• 00822409037032: Cemented Stem 15 EXT
• 00822409037025: Cemented Stem 14 EXT
• 00822409037018: Cemented Stem 13 EXT
• 00822409037001: Cemented Stem 12 EXT
• 00822409036998: Cemented Stem 11 EXT
• 00822409036981: Cemented Stem 10 EXT
• 00822409036875: Cemented Stem 16 STD
• 00822409036868: Cemented Stem 15 STD
• 00822409036851: Cemented Stem 14 STD
• 00822409036844: Cemented Stem 13 STD
• 00822409036837: Cemented Stem 12 STD
• 00822409036820: Cemented Stem 11 STD
• 00822409036813: Cemented Stem 10 STD
• 00822409018901: Alpine Centralizer 18 mm
• 00822409018895: Alpine Centralizer 17 mm
• 00822409018888: Alpine Centralizer 16 mm
• 00822409018871: Alpine Centralizer 15 mm
• 00822409018864: Alpine Centralizer 14 mm
• 00822409018857: Alpine Centralizer 13 mm
• 00822409018840: Alpine Centralizer 12 mm
• 00822409018833: Alpine Centralizer 11 mm
• 00822409018826: Alpine Centralizer 10 mm
• 00822409018819: Alpine Centralizer 9 mm
• 00822409018802: Alpine Centralizer 8 mm
• 00822409000456: Alpine Cemented Stem 16 EXT
• 00822409000449: Alpine Cemented Stem 15 EXT
• 00822409000432: Alpine Cemented Stem 14 EXT
• 00822409000425: Alpine Cemented Stem 13 EXT
• 00822409000418: Alpine Cemented Stem 12 EXT
• 00822409000401: Alpine Cemented Stem 11 EXT
• 00822409000395: Alpine Cemented Stem 10 EXT
• 00822409000333: Alpine Cemented Stem 16 STD
• 00822409000326: Alpine Cemented Stem 15 STD
• 00822409000319: Alpine Cemented Stem 14 STD
• 00822409000302: Alpine Cemented Stem 13 STD
• 00822409000296: Alpine Cemented Stem 12 STD
• 00822409000289: Alpine Cemented Stem 11 STD
• 00822409000272: Alpine Cemented Stem 10 STD