K211238 is an FDA 510(k) clearance for the SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on June 25, 2021, 60 days after receiving the submission on April 26, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K211238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2021 |
| Decision Date | June 25, 2021 |
| Days to Decision | 60 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 |