Exeter X3 Rimfit Acetabular Cup
FDA 510(k) K111848 · Stryker Corp.
510(k) numberK111848
Submission
- Device name
- Exeter X3 Rimfit Acetabular Cup
- Applicant
- Stryker Corp.
Mahwah, NJ, US - Received
- June 29, 2011
- Decision date
- October 5, 2011
- 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 Exeter X3 Rimfit Acetabular Cup cleared by the FDA?
Exeter X3 Rimfit Acetabular Cup (K111848) received a 510(k) decision of Substantially Equivalent on October 5, 2011, 98 days after the submission was received.
What is the product code of K111848?
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.