Modified HPS Hip Prosthesis
FDA 510(k) K833599 · Depuy, Inc.
510(k) numberK833599
Submission
- Device name
- Modified HPS Hip Prosthesis
- Applicant
- Depuy, Inc.
Walker, MI, US - Received
- October 12, 1983
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Modified HPS Hip Prosthesis cleared by the FDA?
Modified HPS Hip Prosthesis (K833599) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 159 days after the submission was received.
What is the product code of K833599?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.