Renovis Cemented Hip System
FDA 510(k) K141370 · Renovis Surgical Technologies, Inc.
510(k) numberK141370
Submission
- Device name
- Renovis Cemented Hip System
- Applicant
- Renovis Surgical Technologies, Inc.
Ashland, MA, US - Received
- May 27, 2014
- Decision date
- September 2, 2014
- 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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Questions and answers
When was Renovis Cemented Hip System cleared by the FDA?
Renovis Cemented Hip System (K141370) received a 510(k) decision of Substantially Equivalent on September 2, 2014, 98 days after the submission was received.
What is the product code of K141370?
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.