K221697 is an FDA 510(k) clearance for the INJECTION PIN (KIP(02031-02061) (03031-03061)). This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Slk Ortho, LLC (Long Grove, US). The FDA issued a Cleared decision on March 3, 2023, 266 days after receiving the submission on June 10, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K221697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2022 |
| Decision Date | March 03, 2023 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN - Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |