Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0
FDA 510(k) K072899 · Aesculap Implant Systems, Inc.
510(k) numberK072899
Submission
- Device name
- Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0
- Applicant
- Aesculap Implant Systems, Inc.
Center Valley, PA, US - Received
- October 11, 2007
- Decision date
- February 6, 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 Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0 cleared by the FDA?
Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0 (K072899) received a 510(k) decision of Substantially Equivalent on February 6, 2008, 118 days after the submission was received.
What is the product code of K072899?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.