Accin Unipolar Head System
FDA 510(k) K080539 · Accelerated Innovation, LLC
510(k) numberK080539
Submission
- Device name
- Accin Unipolar Head System
- Applicant
- Accelerated Innovation, LLC
Clifton, NJ, US - Received
- February 27, 2008
- Decision date
- June 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K081127 | Accin Total Knee SystemJWH · Traditional | 10/17/2008SE |
| K080647 | Accin Bipolar Head SystemKWY · Traditional | 07/08/2008SE |
| K073120 | Accin Patellofemoral SystemKRR · Traditional | 02/29/2008SE |
| K073531 | Accin Pedicle Screw SystemMNH · Traditional | 02/04/2008SE |
| K073530 | Accin Anterior Cervical Plate SystemKWQ · Traditional | 01/31/2008SE |
| K073068 | Accin Hip SystemLPH · Traditional | 01/10/2008SE |
Questions and answers
When was Accin Unipolar Head System cleared by the FDA?
Accin Unipolar Head System (K080539) received a 510(k) decision of Substantially Equivalent on June 2, 2008, 96 days after the submission was received.
What is the product code of K080539?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.