EXACTECH ALL POLY ACETABULAR CUP
FDA 510(k) clearance K934253 · decided 1994-04-29
Clearance details
- K-number
- K934253
- Device name
- EXACTECH ALL POLY ACETABULAR CUP
- Applicant
- Exactech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-31
- Decision date
- 1994-04-29
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- JDZ
- Device class
- 1
- Regulation number
- 888.4210
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gainesville, FL, 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 |
|---|---|---|
| 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 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021) | Exactech, Inc. | 2017-04-03 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020) | Exactech, Inc. | 2016-09-28 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019) | Exactech, Inc. | 2016-07-21 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017) | Exactech, Inc. | 2016-04-26 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018) | Exactech, Inc. | 2015-12-30 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016) | Exactech, Inc. | 2014-06-18 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015) | Exactech, Inc. | 2013-02-07 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014) | Exactech, Inc. | 2012-12-05 |