The following data is part of a premarket notification filed by Biocore9, Llc. with the FDA for Biocore9 Humeral Resurfacing System.
| Device ID | K193122 |
| 510k Number | K193122 |
| Device Name: | Biocore9 Humeral Resurfacing System |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | Biocore9, LLC. 9 Whippany Road, Bldg A1, Unit 12 Whippany, NJ 07981 |
| Contact | Stan Matlak |
| Correspondent | Stephen J. Peoples Biocore9, LLC. 9 Whippany Road, Bldg A1, Unit 12 Whippany, NJ 07981 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810068850048 | K193122 | 000 |
| 00810068850031 | K193122 | 000 |
| 00810068850024 | K193122 | 000 |
| 00810068850017 | K193122 | 000 |