OvertureTi

GUDID 00810129550016

Overture Orthopaedics

Unicondylar knee prosthesis

• Primary Device ID: 00810129550016
• NIH Device Record Key: 5476679c-06fa-469a-87f3-da0e6741e34b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OvertureTi
• Version Model Number: PKG-90-OVR-101730
• Company DUNS: 119105665
• Company Name: Overture Orthopaedics
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Device Dimensions

• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter
• Length: 30 Millimeter
• Width: 17.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810129550016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221292

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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: 2023-10-26
• Device Publish Date: 2023-10-18

On-Brand Devices [OvertureTi]

• 00810129550214: PKG-90-OVR-300022
• 00810129550207: PKG-90-OVR-300020
• 00810129550191: PKG-90-OVR-300017
• 00810129550177: PKG-90-OVR-200025
• 00810129550160: PKG-90-OVR-200022
• 00810129550146: PKG-90-OVR-200017
• 00810129550092: PKG-90-OVR-102240
• 00810129550054: PKG-90-OVR-102035
• 00810129550016: PKG-90-OVR-101730
• 00810129551709: 90-OVR-000550
• 00810129551693: 90-OVR-000500
• 00810129551679: 90-OVR-780025
• 00810129551662: 90-OVR-780022
• 00810129551655: 90-OVR-780020
• 00810129551648: 90-OVR-780017
• 00810129551631: 90-OVR-770000
• 00810129551624: 90-OVR-760000
• 00810129551600: 90-OVR-740000
• 00810129551594: 90-OVR-730000
• 00810129551563: 90-OVR-720522
• 00810129551556: 90-OVR-720520
• 00810129551549: 90-OVR-720517
• 00810129551525: 90-OVR-725025
• 00810129551518: 90-OVR-725022
• 00810129551501: 90-OVR-725020
• 00810129551495: 90-OVR-725017
• 00810129551488: 90-OVR-720000
• 00810129551471: 90-OVR-710000
• 00810129551457: 90-OVR-660025
• 00810129551440: 90-OVR-660022
• 00810129551433: 90-OVR-660020
• 00810129551426: 90-OVR-660017
• 00810129551419: 90-OVR-650022
• 00810129551402: 90-OVR-650020
• 00810129551396: 90-OVR-650017
• 00810129551389: 90-OVR-640017
• 00810129551372: 90-OVR-630022
• 00810129551365: 90-OVR-630020
• 00810129551358: 90-OVR-630017
• 00810129551341: 90-OVR-620022
• 00810129551334: 90-OVR-620020
• 00810129551327: 90-OVR-620017
• 00810129551310: 90-OVR-610022
• 00810129551303: 90-OVR-610020
• 00810129551297: 90-OVR-610017
• 00810129551273: 90-OVR-580025
• 00810129551266: 90-OVR-580022
• 00810129551242: 90-OVR-580017
• 00810129551211: 90-OVR-570022
• 00810129551198: 90-OVR-570017