Orthomix
FDA 510(k) K760636 · Diemolding Corp.
510(k) numberK760636
Submission
- Device name
- Orthomix
- Applicant
- Diemolding Corp.
Mchenry, IL, US - Received
- September 13, 1976
- Decision date
- October 5, 1976
- 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 |
| K853310 | Simplex Enhancement MixerJDZ · Traditional | Howmedica Corp. | 09/11/1985SE |
| 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 |
More from Howmedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…BWF · Traditional | 10/10/1996SE |
| K961455 | Medshield/AerochamberCCQ · Traditional | 07/25/1996SE |
| K902713 | Access. Kit for the Biosurge Synchronous AutotransCAC · Traditional | 07/25/1990SE |
| K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorBSK · Traditional | 07/18/1990SE |
| K900754 | Respirex 2BWF · Traditional | 03/15/1990SE |
| K893791 | Breathing MouthpieceBYP · Traditional | 06/23/1989SE |
| K781759 | RescalBZA · Traditional | 11/27/1978SE |
| K780750 | O2 ConnectorCAN · Traditional | 07/27/1978SE |
| K770369 | Vacon TMCBD · Traditional | 03/01/1977SE |
| K760931 | I.V. Drip Monitor Alarm Device, MonifloFLN · Traditional | 01/05/1977SE |
Questions and answers
When was Orthomix cleared by the FDA?
Orthomix (K760636) received a 510(k) decision of Substantially Equivalent on October 5, 1976, 22 days after the submission was received.
What is the product code of K760636?
The FDA product code is JDZ – Mixer, Cement, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 888.4210.