Medical Device Manufacturer · US , Fort Wayne , IN

BioPoly, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - BioPoly, LLC Orthopedic ✕
3 devices
1-3 of 3
Cleared Mar 13, 2024
BioPoly Radial Head Implant
K233592 · KWI
Orthopedic · 126d
Cleared Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964 · KWD
Orthopedic · 56d
Cleared Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · KWD
Orthopedic · 53d
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