Vectorvision Knee
FDA 510(k) K010612 · Brainlab AG
510(k) numberK010612
Submission
- Device name
- Vectorvision Knee
- Applicant
- Brainlab AG
Heimstetten, DE - Received
- March 1, 2001
- Decision date
- September 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vectorvision Knee cleared by the FDA?
Vectorvision Knee (K010612) received a 510(k) decision of Substantially Equivalent on September 6, 2001, 189 days after the submission was received.
What is the product code of K010612?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.