Acumatch L-Series 102-20-55

GUDID 10885862012012

Exactech, Inc.

Metallic femoral head prosthesis

• Primary Device ID: 10885862012012
• NIH Device Record Key: 96024c0c-81d5-4640-af3f-6097f12ffe78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acumatch L-Series
• Version Model Number: 102-20-55
• Catalog Number: 102-20-55
• 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: 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

• Outer Diameter: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862012012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010081

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-10-30