Acumatch C Series 116-01-04

GUDID 10885862018304

Exactech, Inc.

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 10885862018304
• NIH Device Record Key: 7eb1d80f-19c6-4251-954f-8d92f2374fca
• Commercial Distribution Discontinuation: 2020-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acumatch C Series
• Version Model Number: 116-01-04
• Catalog Number: 116-01-04
• 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
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862018304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052787

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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: 2025-08-28
• Device Publish Date: 2015-08-10

On-Brand Devices [Acumatch C Series]

• 10885862018380: 116-30-06
• 10885862018373: 116-30-05
• 10885862018366: 116-30-04
• 10885862018359: 116-30-03
• 10885862018342: 116-30-02
• 10885862018335: 116-30-01
• 10885862018311: 116-01-05
• 10885862018304: 116-01-04
• 10885862018298: 116-01-03
• 10885862018281: 116-01-02
• 10885862018274: 116-01-01
• 10885862018328: 116-01-06