Submission Details
| 510(k) Number | K202393 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 2020 |
| Decision Date | October 20, 2020 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
SpineJack Expansion Kit
Oct 2020
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K202393 is an FDA 510(k) clearance for the SpineJack Expansion Kit, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on October 20, 2020, 60 days after receiving the submission on August 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.
Device Classification
| Product Code | NDN — Cement, Bone, Vertebroplasty |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3027 |
Manufacturer
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