FDA 510(k), K172301, Mako Partial Knee Application
FDA 510(k), K172301, Mako Partial Knee Application
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510(K) Number: K172301
Device Name: Mako Partial Knee Application
Manufacturer: MAKO Surgical Corp.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 07/31/2017
Decision Date: 11/02/2017
Regulation Medical Specialty: Neurology
Device Name: Mako Partial Knee Application
Manufacturer: MAKO Surgical Corp.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 07/31/2017
Decision Date: 11/02/2017
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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