DynaBridge

Staple, Fixation, Bone

Fusion Orthopedics, LLC

The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Dynabridge.

Pre-market Notification Details

• Device ID: K181815
• 510k Number: K181815
• Device Name: DynaBridge
• Classification: Staple, Fixation, Bone
• Applicant: Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212
• Contact: Adam Cundiff
• Correspondent: J. D. Webb; The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
• Product Code: JDR
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-09
• Decision Date: 2018-10-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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