STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
FDA 510(k) clearance K912190 · decided 1991-08-29
Clearance details
- K-number
- K912190
- Device name
- STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-17
- Decision date
- 1991-08-29
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- JDZ
- Device class
- 1
- Regulation number
- 888.4210
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EXACTECH ALL POLY ACETABULAR CUP (K934253) | Exactech, Inc. | 1994-04-29 |
| PRISM BONE CEMENT MIXING SYSTEM (K925025) | Depuy, Inc. | 1994-01-05 |
| REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (K892937) | Dentsply Intl. | 1989-06-22 |
| ZIMMER VACUUM MIXING SYSTEM (K861086) | Zimmer, Inc. | 1986-04-14 |
| MIX EVAC II (K854077) | Stryker Corp. | 1986-01-31 |
| SIMPLEX ENHANCEMENT MIXER (K853310) | Howmedica Corp. | 1985-09-11 |
| CEMENTRIFUGE (K851205) | Biodynamic Technologies, Inc. | 1985-07-16 |
| ZIMMER BONE CEMENT CENTRIFUGATION SYS (K843219) | Zimmer, Inc. | 1984-11-29 |
| HOWMEDICA MIX-KIT II (K792186) | Howmedica Corp. | 1979-12-05 |
| MIXING BOWL & SPATULA, DISPOSABLE (K780857) | Howmedica Corp. | 1978-06-13 |
| ORTHOMIX (K760636) | Diemolding Corp. | 1976-10-05 |
| MIX EVAC BONE CEMENT (K760617) | Stryker Corp. | 1976-10-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , recall (Z-0862-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-01-25 |
| Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away F recall (Z-0921-03) | Stryker Instruments, Instruments Div. | 2003-07-29 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |