Stability Femoral Prosthesis W/Hap
FDA 510(k) K915655 · Depuy, Inc.
510(k) numberK915655
Submission
- Device name
- Stability Femoral Prosthesis W/Hap
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- December 18, 1991
- Decision date
- February 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Stability Femoral Prosthesis W/Hap cleared by the FDA?
Stability Femoral Prosthesis W/Hap (K915655) received a 510(k) decision of Substantially Equivalent on February 14, 1994, 789 days after the submission was received.
What is the product code of K915655?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.