Medical Device Manufacturer · US , Fort Wayne , IN

BioPoly, LLC

3 submissions · 3 cleared · Since 2021
3
Total
3
Cleared
0
Denied

BioPoly, LLC — FDA 510(k) Submissions

BioPoly, LLC has submitted 3 FDA 510(k) premarket notifications since 2021, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Toe, Hemi-, Phalangeal, Prosthesis, Elbow, Hemi-, Radial, Polymer . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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All3 Orthopedic 3