Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
FDA 510(k) clearance K150582 · decided 2015-06-12
Clearance details
- K-number
- K150582
- Device name
- Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
- Applicant
- Stryker Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-03-09
- Decision date
- 2015-06-12
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605- recall (Z-2536-2016) | Stryker Instruments Div. of Stryker Corporation | 2016-08-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005) | Stryker Corporation | 2016-08-09 |
| SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004) | Stryker Corporation | 2007-09-28 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003) | Stryker Corporation | 2002-12-31 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002) | Stryker Corporation | 1998-06-04 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001) | Stryker Corporation | 1998-06-04 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053) | Stryker Corporation | 1997-06-19 |