The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Vertaplex Hv High Viscosity Radiopaque Bone Cement; Es2 Augmentable Spinal System.
| Device ID | K192818 |
| 510k Number | K192818 |
| Device Name: | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System |
| Classification | Bone Cement, Posterior Screw Augmentation |
| Applicant | Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Contact | Kristi Ashton |
| Correspondent | Kristi Ashton Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Product Code | PML |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NDN |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-03-31 |
| Summary: | summary |