Contour Femoral Hip Stem with Porocoat
FDA 510(k) K926120 · Depuy, Inc.
510(k) numberK926120
Submission
- Device name
- Contour Femoral Hip Stem with Porocoat
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- December 3, 1992
- Decision date
- March 31, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Contour Femoral Hip Stem with Porocoat cleared by the FDA?
Contour Femoral Hip Stem with Porocoat (K926120) received a 510(k) decision of Substantially Equivalent on March 31, 1993, 118 days after the submission was received.
What is the product code of K926120?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.