Fixion Hip System
FDA 510(k) K032730 · Disc-O-Tech Medical Technologies, Ltd.
510(k) numberK032730
Submission
- Device name
- Fixion Hip System
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
Herzelia, IL - Received
- September 3, 2003
- Decision date
- March 26, 2004
- 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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| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)NDN · Traditional | 12/21/2007SE |
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| K063067 | Confidence Fenestrated Introducer NeedleNDN · Special | 11/03/2006SE |
| K062424 | Confidence Ex High Viscosity Bone CementNDN · Special | 09/14/2006SE |
| K060300 | Confidence High Viscosity Bone CementNDN · Traditional | 06/21/2006SE |
| K040612 | Sky Bone Expander System (Sky System)HRX · Traditional | 06/17/2004SE |
| K040939 | Sky Bone Expander System (Sky System)HRX · Special | 05/12/2004SE |
| K034037 | Sky Bone Expander SystemHRX · Special | 01/28/2004SE |
| K032358 | B-Twin Bone Expander System (B-Twin Be System)HRX · Traditional | 12/17/2003SE |
| K030972 | Fixion Unipolar Modular Hemi-Hip System (Fixion MH)KWL · Special | 05/30/2003SE |
Questions and answers
When was Fixion Hip System cleared by the FDA?
Fixion Hip System (K032730) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 205 days after the submission was received.
What is the product code of K032730?
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.