K231087 is an FDA 510(k) clearance for the Guided Surgery Kit. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on August 16, 2023, 121 days after receiving the submission on April 17, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K231087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2023 |
| Decision Date | August 16, 2023 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DZI - Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |