Simplex Enhancement Mixer
FDA 510(k) K853310 · Howmedica Corp.
510(k) numberK853310
Submission
- Device name
- Simplex Enhancement Mixer
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- August 7, 1985
- Decision date
- September 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDZ – Mixer, Cement, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4210
- Specialty
- Orthopedic
Other 510(k)s with product code JDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934253 | Exactech All Poly Acetabular CupJDZ · Traditional | Exactech, Inc. | 04/29/1994SE |
| K925025 | Prism Bone Cement Mixing SystemJDZ · Traditional | Depuy, Inc. | 01/05/1994SE |
| K912190 | Stryker High Vacuum Bone Cement Mixer/Inject SystJDZ · Traditional | Stryker Corp. | 08/29/1991SE |
| K892937 | Reusable Bowl and Spatula for Mixing Bone CementsJDZ · Traditional | Dentsply Intl. | 06/22/1989SE |
| K861086 | Zimmer Vacuum Mixing SystemJDZ · Traditional | Zimmer, Inc. | 04/14/1986SE |
| K854077 | Mix Evac IIJDZ · Traditional | Stryker Corp. | 01/31/1986SN |
| K851205 | CementrifugeJDZ · Traditional | Biodynamic Technologies, Inc. | 07/16/1985SE |
| K843219 | Zimmer Bone Cement Centrifugation SysJDZ · Traditional | Zimmer, Inc. | 11/29/1984SE |
| K792186 | Howmedica Mix-Kit IIJDZ · Traditional | Howmedica Corp. | 12/05/1979SE |
| K780857 | Mixing Bowl & Spatula, DisposableJDZ · Traditional | Howmedica Corp. | 06/13/1978SE |
More from Howmedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Simplex Enhancement Mixer cleared by the FDA?
Simplex Enhancement Mixer (K853310) received a 510(k) decision of Substantially Equivalent on September 11, 1985, 35 days after the submission was received.
What is the product code of K853310?
The FDA product code is JDZ – Mixer, Cement, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 888.4210.