ZIMMER VACUUM MIXING SYSTEM
FDA 510(k) clearance K861086 · decided 1986-04-14
Clearance details
- K-number
- K861086
- Device name
- ZIMMER VACUUM MIXING SYSTEM
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-21
- Decision date
- 1986-04-14
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JDZ
- Device class
- 1
- Regulation number
- 888.4210
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |