The C-Fit & Dc-Fit Acetabular Cup System
FDA 510(k) K972995 · Corin USA
510(k) numberK972995
Submission
- Device name
- The C-Fit & Dc-Fit Acetabular Cup System
- Applicant
- Corin USA
Tampa, FL, US - Received
- August 12, 1997
- Decision date
- November 10, 1997
- 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 The C-Fit & Dc-Fit Acetabular Cup System cleared by the FDA?
The C-Fit & Dc-Fit Acetabular Cup System (K972995) received a 510(k) decision of Substantially Equivalent on November 10, 1997, 90 days after the submission was received.
What is the product code of K972995?
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.