Exactech All Poly Acetabular Cup
FDA 510(k) K934253 · Exactech, Inc.
510(k) numberK934253
Submission
- Device name
- Exactech All Poly Acetabular Cup
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- August 31, 1993
- Decision date
- April 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K780857 | Mixing Bowl & Spatula, DisposableJDZ · Traditional | Howmedica Corp. | 06/13/1978SE |
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Questions and answers
When was Exactech All Poly Acetabular Cup cleared by the FDA?
Exactech All Poly Acetabular Cup (K934253) received a 510(k) decision of Substantially Equivalent on April 29, 1994, 241 days after the submission was received.
What is the product code of K934253?
The FDA product code is JDZ – Mixer, Cement, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 888.4210.