Medacta Total Hip Prosthesis System - Line Extension
FDA 510(k) K080885 · Medacta International S.A.
510(k) numberK080885
Submission
- Device name
- Medacta Total Hip Prosthesis System - Line Extension
- Applicant
- Medacta International S.A.
San Diego, CA, US - Received
- March 31, 2008
- Decision date
- April 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Medacta Total Hip Prosthesis System - Line Extension cleared by the FDA?
Medacta Total Hip Prosthesis System - Line Extension (K080885) received a 510(k) decision of Substantially Equivalent on April 28, 2008, 28 days after the submission was received.
What is the product code of K080885?
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.