Submission Details
| 510(k) Number | K223294 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 2022 |
| Decision Date | December 20, 2022 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
SpineJack? Expansion Kit
Dec 2022
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K223294 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 Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 20, 2022, 55 days after receiving the submission on October 26, 2022. 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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