The following data is part of a premarket notification filed by Biocore9 Llc with the FDA for Biocore9 Femoral Head Resurfacing Component.
| Device ID | K201219 |
| 510k Number | K201219 |
| Device Name: | Biocore9 Femoral Head Resurfacing Component |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | BioCore9 LLC 9 Whippany Road, BLDG A1, Unit 12 Whippany, NJ 07981 |
| Contact | Stan Matlak |
| Correspondent | Steve Peoples BioCore9 LLC 9 Whippany Road, BLDG A1, Unit 12 A Whippany, NJ 07981 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-06 |
| Decision Date | 2021-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810068850468 | K201219 | 000 |
| 00810068850451 | K201219 | 000 |
| 00810068850444 | K201219 | 000 |
| 00810068850437 | K201219 | 000 |
| 00810068850420 | K201219 | 000 |
| 00810068850413 | K201219 | 000 |
| 00810068850406 | K201219 | 000 |
| 00810068850390 | K201219 | 000 |
| 00810068850383 | K201219 | 000 |