Axis Plating System

Plate, Fixation, Bone

Extremity Medical, LLC.

The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Axis Plating System.

Pre-market Notification Details

• Device ID: K192592
• 510k Number: K192592
• Device Name: Axis Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
• Contact: Brian Smekal
• Correspondent: Brian Smekal; Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
• Product Code: HRS
• Subsequent Product Code: HTN
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-20
• Decision Date: 2019-11-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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