SIMPLEX ENHANCEMENT MIXER
FDA 510(k) clearance K853310 · decided 1985-09-11
Clearance details
- K-number
- K853310
- Device name
- SIMPLEX ENHANCEMENT MIXER
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-07
- Decision date
- 1985-09-11
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JDZ
- Device class
- 1
- Regulation number
- 888.4210
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, 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 |
| STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190) | Stryker Corp. | 1991-08-29 |
| 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 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |