Medical Device Manufacturer · US , Whippany , NJ

Biocore9, LLC

3 submissions · 3 cleared · Since 2020
3
Total
3
Cleared
0
Denied

Biocore9, LLC — FDA 510(k) Submissions

Biocore9, LLC has submitted 3 FDA 510(k) premarket notifications since 2020, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, Prosthesis, Hip, Femoral, Resurfacing, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
Filters
All3 Orthopedic 3