The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Spinejack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex Hv Radiopaque Bone Cement.
| Device ID | K211238 |
| 510k Number | K211238 |
| Device Name: | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Stryker Instruments 1941 Stryker Way Portage, MI 49002 |
| Contact | Susanne Galin |
| Correspondent | Susanne Galin Stryker Instruments 1941 Stryker Way Portage, MI 49002 |
| Product Code | NDN |
| Subsequent Product Code | LOD |
| Subsequent Product Code | PML |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-06-25 |