AcuMatch M-Series 158-02-95

GUDID 10885862031631

Exactech, Inc.

Press-fit hip femur prosthesis, modular

• Primary Device ID: 10885862031631
• NIH Device Record Key: dcb8d933-2a27-4402-95c8-cd5657e36457
• Commercial Distribution Discontinuation: 2024-06-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AcuMatch M-Series
• Version Model Number: 158-02-95
• Catalog Number: 158-02-95
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862031631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051858

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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: 2025-09-03
• Device Publish Date: 2015-10-30

On-Brand Devices [AcuMatch M-Series]

• 10885862629432: Femoral Head Impactor