Cementrifuge
FDA 510(k) K851205 · Biodynamic Technologies, Inc.
510(k) numberK851205
Submission
- Device name
- Cementrifuge
- Applicant
- Biodynamic Technologies, Inc.
Arlington, VA, US - Received
- March 26, 1985
- Decision date
- July 16, 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 |
| K853310 | Simplex Enhancement MixerJDZ · Traditional | Howmedica Corp. | 09/11/1985SE |
| 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 |
|---|---|---|
| K990436 | Ultimax Trochanteric Intramedullary Rod SystemHSB · Traditional | 03/31/1999SE |
| K990513 | Ultimax Cortical Bone ScrewsHWC · Traditional | 03/17/1999SE |
| K990481 | Ultimax Distal Radial (Volar) Locking Plate SystemHRS · Traditional | 03/17/1999SE |
| K981230 | Ultimax Distal Femoral Intramedullary Rod SystemHSB · Traditional | 06/01/1998SE |
| K980102 | Bti Humeral Intramedullary Rod SystemHSB · Traditional | 04/03/1998SE |
| K974756 | Bti Large (7.0MM) Cannulated Transfixing ScrewsHWC · Traditional | 03/12/1998SN |
| K972403 | Bti Cortical Bone ScrewsHWC · Traditional | 08/29/1997SE |
| K970897 | Bti Distal Femoral Intramedullary Rod SystemHSB · Traditional | 04/21/1997SE |
| K962706 | Ez-Fix Cannulated Screw SystemHWC · Traditional | 11/13/1996SE |
| K962987 | Ez-Fix Small Cannulated Screw SystemHWC · Traditional | 11/04/1996SE |
Questions and answers
When was Cementrifuge cleared by the FDA?
Cementrifuge (K851205) received a 510(k) decision of Substantially Equivalent on July 16, 1985, 112 days after the submission was received.
What is the product code of K851205?
The FDA product code is JDZ – Mixer, Cement, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 888.4210.