Ovation Hip Stem

GUDID 00822409011186

EXT Size 11 Stem Plasma Spray

Ortho Development Corporation

Coated hip femur prosthesis, modular

• Primary Device ID: 00822409011186
• NIH Device Record Key: b2144e8e-f2a9-4be8-b0a7-1184cf272e55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation Hip Stem
• Version Model Number: 101-1011
• 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	00822409011186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062775

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 [Ovation Hip Stem]

• 00822409011216: EXT Size 2 12/14 Stem Plasma Spray
• 00822409011186: EXT Size 11 Stem Plasma Spray
• 00822409011179: EXT Size 10 Stem Plasma Spray
• 00822409011162: EXT Size 9 Stem Plasma Spray
• 00822409011155: EXT Size 8 Stem Plasma Spray
• 00822409011148: EXT Size 7 Stem Plasma Spray
• 00822409011131: EXT Size 6 Stem Plasma Spray
• 00822409011124: EXT Size 5 Stem Plasma Spray
• 00822409011117: EXT Size 4 Stem Plasma Spray
• 00822409011100: EXT Size 3 Stem Plasma Spray
• 00822409011094: EXT Size 2 Stem Plasma Spray
• 00822409011087: EXT Size 1 Stem Plasma Spray
• 00822409010912: STD Size 12 Stem Plasma Spray
• 00822409010905: STD Size 11 Stem Plasma Spray
• 00822409010899: STD Size 10 Stem Plasma Spray
• 00822409010882: STD Size 9 Stem Plasma Spray
• 00822409010875: STD Size 8 Stem Plasma Spray
• 00822409010868: STD Size 7 Stem Plasma Spray
• 00822409010851: STD Size 6 Stem Plasma Spray
• 00822409010844: STD Size 5 Stem Plasma Spray
• 00822409010837: STD Size 4 Stem Plasma Spray
• 00822409010820: STD Size 3 Stem Plasma Spray
• 00822409010813: STD Size 2 Stem Plasma Spray
• 00822409010806: STD Size 1 Stem Plasma Spray