Acumatch L Series 118-20-02

GUDID 10885862019127

Exactech, Inc.

Press-fit femoral stem prosthesis

• Primary Device ID: 10885862019127
• NIH Device Record Key: 9791ac42-31e0-4942-8287-79508a557e23
• Commercial Distribution Discontinuation: 2020-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acumatch L Series
• Version Model Number: 118-20-02
• Catalog Number: 118-20-02
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 145 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862019127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041906

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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: 2025-08-28
• Device Publish Date: 2015-08-10

On-Brand Devices [Acumatch L Series]

• 10885862019165: 118-20-06
• 10885862019158: 118-20-05
• 10885862019141: 118-20-04
• 10885862019134: 118-20-03
• 10885862019127: 118-20-02
• 10885862019110: 118-20-01
• 10885862019103: 118-20-00
• 10885862016300: 110-40-05
• 10885862016294: 110-40-04
• 10885862016287: 110-40-03
• 10885862016263: 110-40-01
• 10885862016256: 110-01-05
• 10885862016249: 110-01-04
• 10885862016232: 110-01-03
• 10885862016225: 110-01-02
• 10885862016218: 110-01-01
• 10885862016270: 110-40-02