FitRite Total Hip Arthroplasty System
FDA 510(k) K153057 · Excera Orthopedics, Inc.
510(k) numberK153057
Submission
- Device name
- FitRite Total Hip Arthroplasty System
- Applicant
- Excera Orthopedics, Inc.
Newton, MA, US - Received
- October 21, 2015
- Decision date
- June 23, 2016
- 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 |
|---|---|---|
| K140547 | Excera Fitrite Total Hip Arthroplasty SystemLPH · Traditional | 01/22/2015SE |
Questions and answers
When was FitRite Total Hip Arthroplasty System cleared by the FDA?
FitRite Total Hip Arthroplasty System (K153057) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 246 days after the submission was received.
What is the product code of K153057?
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.