Virtuoso-Stereotaxic Planning Software
FDA 510(k) K991706 · Stryker Corp.
510(k) numberK991706
Submission
- Device name
- Virtuoso-Stereotaxic Planning Software
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- May 19, 1999
- Decision date
- December 7, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Virtuoso-Stereotaxic Planning Software cleared by the FDA?
Virtuoso-Stereotaxic Planning Software (K991706) received a 510(k) decision of Substantially Equivalent on December 7, 1999, 202 days after the submission was received.
What is the product code of K991706?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.