Keane Uni Knee System with Porocoat
FDA 510(k) K921232 · Depuy, Inc.
510(k) numberK921232
Submission
- Device name
- Keane Uni Knee System with Porocoat
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- March 13, 1992
- Decision date
- June 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Keane Uni Knee System with Porocoat cleared by the FDA?
Keane Uni Knee System with Porocoat (K921232) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 88 days after the submission was received.
What is the product code of K921232?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.