Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
Cement, Bone, Vertebroplasty
STRYKER CORPORATION
The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Vertaplex® High Viscosity (hv) Radiopaque Bone Cement.
Pre-market Notification Details
| Device ID | K150582 |
| 510k Number | K150582 |
| Device Name: | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| Classification | Cement, Bone, Vertebroplasty |
| 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 | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327357852 | K150582 | 000 |
Trademark Results [Vertaplex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTAPLEX 77194100 3531818 Live/Registered |
STRYKER CORPORATION 2007-05-31 |
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