Optetrak 204-13-11

GUDID 10885862047953

Exactech, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 10885862047953
• NIH Device Record Key: 5a04bc5a-3c6c-4982-ae9a-7873885b1a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optetrak
• Version Model Number: 204-13-11
• Catalog Number: 204-13-11
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• 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

Device Dimensions

• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862047953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933494

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-30