FDA.report

510(k) K170581

Device
Mako Total Knee Application
Applicant
MAKO Surgical Corp.
510(k) number
K170581
Product code
OLO  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-11
Date received
2017-02-28
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Shikha Khandelwal
Address
2555 Davie Rd. Fort Lauderdale FL US 33317 33317

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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