The following data is part of a premarket notification filed by Centermed, Inc. with the FDA for Centermed Patient Matched Assisted Surgical Planning (asp) System.
| Device ID | K211614 |
| 510k Number | K211614 |
| Device Name: | CenterMed Patient Matched Assisted Surgical Planning (ASP) System |
| Classification | Orthopaedic Surgical Planning And Instrument Guides |
| Applicant | CenterMed, Inc. 226 N Wiget Ln Walnut Creek, CA 94598 |
| Contact | Jash Bhayani |
| Correspondent | Jash Bhayani CenterMed, Inc. 226 N Wiget Ln Walnut Creek, CA 94598 |
| Product Code | PBF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-26 |
| Decision Date | 2022-08-04 |