Mako Surgical Tactile Guidance System Version 2.0
FDA 510(k) K081867 · Mako Surgical Corp.
510(k) numberK081867
Submission
- Device name
- Mako Surgical Tactile Guidance System Version 2.0
- Applicant
- Mako Surgical Corp.
Fort Lauderdale, FL, US - Received
- July 1, 2008
- Decision date
- November 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mako Surgical Tactile Guidance System Version 2.0 cleared by the FDA?
Mako Surgical Tactile Guidance System Version 2.0 (K081867) received a 510(k) decision of Substantially Equivalent on November 25, 2008, 147 days after the submission was received.
What is the product code of K081867?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.