Ovation Tribute Hip Stem

GUDID 00822409011322

EXT SIZE 11 Stem Plasma Spray

Ortho Development Corporation

Coated hip femur prosthesis, modular

• Primary Device ID: 00822409011322
• NIH Device Record Key: 7e71fecc-6995-47e4-8eff-e1f1e4999129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation Tribute Hip Stem
• Version Model Number: 101-1311
• 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	00822409011322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133386

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 Tribute Hip Stem]

• 00822409033010: EXT Size 11.5 Stem Plasma Spray
• 00822409033003: EXT Size 10.5 Stem Plasma Spray
• 00822409032990: STD Size 11.5 Stem Plasma Spray
• 00822409032983: STD Size 10.5 Stem Plasma Spray
• 00822409011353: EXT SIZE 9.5 Stem Plasma Spray
• 00822409011346: EXT SIZE 8.5 Stem Plasma Spray
• 00822409011339: EXT SIZE 12 Stem Plasma Spray
• 00822409011322: EXT SIZE 11 Stem Plasma Spray
• 00822409011315: EXT SIZE 10 Stem Plasma Spray
• 00822409011308: EXT SIZE 9 Stem Plasma Spray
• 00822409011292: EXT SIZE 8 Stem Plasma Spray
• 00822409011285: EXT SIZE 7 Stem Plasma Spray
• 00822409011278: EXT SIZE 6 Stem Plasma Spray
• 00822409011261: EXT SIZE 5 Stem Plasma Spray
• 00822409011254: EXT SIZE 4 Stem Plasma Spray
• 00822409011247: EXT SIZE 3 Stem Plasma Spray
• 00822409011230: EXT SIZE 2 Stem Plasma Spray
• 00822409011223: EXT SIZE 1 Stem Plasma Spray
• 00822409011070: STD SIZE 9.5 Stem Plasma Spray
• 00822409011063: STD SIZE 8.5 Stem Plasma Spray
• 00822409011056: STD SIZE 12 Stem Plasma Spray
• 00822409011049: STD SIZE 11 Stem Plasma Spray
• 00822409011032: STD SIZE 10 Stem Plasma Spray
• 00822409011025: STD SIZE 9 Stem Plasma Spray
• 00822409011018: STD SIZE 8 Stem Plasma Spray
• 00822409011001: STD SIZE 7 Stem Plasma Spray
• 00822409010998: STD SIZE 6 Stem Plasma Spray
• 00822409010981: STD SIZE 5 Stem Plasma Spray
• 00822409010974: STD SIZE 4 Stem Plasma Spray
• 00822409010967: STD SIZE 3 Stem Plasma Spray
• 00822409010950: STD SIZE 2 Stem Plasma Spray
• 00822409010943: STD SIZE 1 Stem Plasma Spray