Arrowhead Hexapod Fixator

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Arrowhead DE, LLC

The following data is part of a premarket notification filed by Arrowhead De, Llc with the FDA for Arrowhead Hexapod Fixator.

Pre-market Notification Details

• Device ID: K190069
• 510k Number: K190069
• Device Name: Arrowhead Hexapod Fixator
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: Arrowhead DE, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017
• Contact: Thomas J. Twardzik
• Correspondent: Patrick Mullaney; Arrowhead DE, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017
• Product Code: KTT
• Subsequent Product Code: HTY
• Subsequent Product Code: OSN
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-15
• Decision Date: 2019-05-14
• Summary: summary

NIH GUDID Devices

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