K201353 is an FDA 510(k) clearance for the CenterMed Patient Matched Assisted Surgical Planning (ASP) System. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by Centermed, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on June 28, 2021, 403 days after receiving the submission on May 21, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K201353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2020 |
| Decision Date | June 28, 2021 |
| Days to Decision | 403 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZJ - Driver, Wire, And Bone Drill, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |