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 |