Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1
FDA 510(k) K082267 · Smith & Nephew, Inc.
510(k) numberK082267
Submission
- Device name
- Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- August 11, 2008
- Decision date
- October 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1 cleared by the FDA?
Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1 (K082267) received a 510(k) decision of Substantially Equivalent on October 29, 2008, 79 days after the submission was received.
What is the product code of K082267?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.