Ovation

GUDID 00822409121403

Narrow Stem Size 10.5 EXT

Ortho Development Corporation

Coated hip femur prosthesis, modular

• Primary Device ID: 00822409121403
• NIH Device Record Key: bd057fc0-32c1-4a7d-9673-1a7e7eaa820d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation
• Version Model Number: 101-1496
• 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
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• 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	00822409121403 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-21

On-Brand Devices [Ovation]

• 00822409121434: Narrow Stem Size 12 EXT
• 00822409121427: Narrow Stem Size 11.5 EXT
• 00822409121410: Narrow Stem Size 11 EXT
• 00822409121403: Narrow Stem Size 10.5 EXT
• 00822409121397: Narrow Stem Size 10 EXT
• 00822409121380: Narrow Stem Size 9.5 EXT
• 00822409121373: Narrow Stem Size 9 EXT
• 00822409121366: Narrow Stem Size 8.5 EXT
• 00822409121359: Narrow Stem Size 8 EXT
• 00822409121342: Narrow Stem Size 7 EXT
• 00822409121335: Narrow Stem Size 6 EXT
• 00822409121328: Narrow Stem Size 5 EXT
• 00822409121311: Narrow Stem Size 4 EXT
• 00822409121304: Narrow Stem Size 12 STD
• 00822409121298: Narrow Stem Size 11.5 STD
• 00822409121281: Narrow Stem Size 11 STD
• 00822409121274: Narrow Stem Size 10.5 STD
• 00822409121267: Narrow Stem Size 10 STD
• 00822409121250: Narrow Stem Size 9.5 STD
• 00822409121243: Narrow Stem Size 9 STD
• 00822409121236: Narrow Stem Size 8.5 STD
• 00822409121229: Narrow Stem Size 8 STD
• 00822409121212: Narrow Stem Size 7 STD
• 00822409121205: Narrow Stem Size 6 STD
• 00822409121199: Narrow Stem Size 5 STD
• 00822409121182: Narrow Stem Size 4 STD