Medical Device Manufacturer · US , Whippany , NJ

Biocore9, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biocore9, LLC Orthopedic ✕
3 devices
1-3 of 3
Cleared May 17, 2022
Biocore9 Acetabular Cup System
K212761 · LPH
Orthopedic · 259d
Cleared Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219 · KXA
Orthopedic · 258d
Cleared May 15, 2020
Biocore9 Humeral Resurfacing System
K193122 · HSD
Orthopedic · 185d
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