Pigalileo Total Knee Replacement (TKR) System
FDA 510(k) K061362 · Plus Orthopedics AG
510(k) numberK061362
Submission
- Device name
- Pigalileo Total Knee Replacement (TKR) System
- Applicant
- Plus Orthopedics AG
Norfolk, MA, US - Received
- May 16, 2006
- Decision date
- October 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pigalileo Total Knee Replacement (TKR) System cleared by the FDA?
Pigalileo Total Knee Replacement (TKR) System (K061362) received a 510(k) decision of Substantially Equivalent on October 6, 2006, 143 days after the submission was received.
What is the product code of K061362?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.