Aesculap Orthopilot 2 Tha V 2.0
FDA 510(k) K050752 · Aesculap, Inc.
510(k) numberK050752
Submission
- Device name
- Aesculap Orthopilot 2 Tha V 2.0
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- March 23, 2005
- Decision date
- April 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aesculap Orthopilot 2 Tha V 2.0 cleared by the FDA?
Aesculap Orthopilot 2 Tha V 2.0 (K050752) received a 510(k) decision of Substantially Equivalent on April 27, 2005, 35 days after the submission was received.
What is the product code of K050752?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.