The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Vertaplex Radiopaque Bone Cement.
| Device ID | K072118 |
| 510k Number | K072118 |
| Device Name: | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean Sheppard |
| Correspondent | Jean Sheppard STRYKER CORP. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2007-12-07 |
| Summary: | summary |