Data / Medical devices / United States / Biocore9 LLC
Biocore9 LLC: FDA-registered device maker in Denville, NJ, United States, 3 510(k) clearances
Biocore9 LLC is registered with the FDA (registration 3020162561) in Denville, NJ, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020162561
- Address
- 30 Broad Street Ste 3 B, Denville, NJ, United States, 07834
- Owner or operator
- Biocore9 LLC (10082626)
- Roles
- Manufacturer
- First device listed
- August 27, 2021
- Registered through
- 2026
- Brand names listed
- Biocore9 Acetabular Cup System, Biocore9 Femoral Head Resurfacing Component, Biocore9 Humeral Head Resurfacing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Hip, Femoral, Resurfacing | KXA | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 17, 2022 | K212761 | Biocore9 Acetabular Cup System | LPH | Substantially Equivalent | Biocore9, LLC | accessdata.fda.gov |
| January 19, 2021 | K201219 | Biocore9 Femoral Head Resurfacing Component | KXA | Substantially Equivalent | Biocore9, LLC | accessdata.fda.gov |
| May 15, 2020 | K193122 | Biocore9 Humeral Resurfacing System | HSD | Substantially Equivalent | Biocore9, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Femoral, Resurfacing
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Updated May 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.