Alpha Porous Coated Femoral Component (Subject to Wmti Marketing Approval)
FDA 510(k) K950418 · Wrightmedicaltechnologyinc
510(k) numberK950418
Submission
- Device name
- Alpha Porous Coated Femoral Component (Subject to Wmti Marketing Approval)
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- January 31, 1995
- Decision date
- June 15, 1995
- 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 Alpha Porous Coated Femoral Component (Subject to Wmti Marketing Approval) cleared by the FDA?
Alpha Porous Coated Femoral Component (Subject to Wmti Marketing Approval) (K950418) received a 510(k) decision of Substantially Equivalent on June 15, 1995, 135 days after the submission was received.
What is the product code of K950418?
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.