Repicci II Onlay Unicompartmental Tibial Component
FDA 510(k) K053299 · Biomet Manufacturing, Inc.
510(k) numberK053299
Submission
- Device name
- Repicci II Onlay Unicompartmental Tibial Component
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- November 25, 2005
- Decision date
- January 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Specialty
- Orthopedic
- Implant
- Yes
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| K110415 | Signature Planner / Signature GuidesHRY · Traditional | Materialise NV | 05/16/2011SE |
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Questions and answers
When was Repicci II Onlay Unicompartmental Tibial Component cleared by the FDA?
Repicci II Onlay Unicompartmental Tibial Component (K053299) received a 510(k) decision of Substantially Equivalent on January 5, 2006, 41 days after the submission was received.
What is the product code of K053299?
The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.