DeviceClearance

Mako Total Knee Application— 510(k) K193515

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K193515 for Mako Total Knee Application, Substantially Equivalent on 2020-07-14. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant
Mako Surgical Corp.
Product code
Code OLO
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Lauderdale, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OLO

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More clearances from Mako Surgical Corp.

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Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K193515

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193515.

Data sourced from openFDA. This site is unofficial and independent of the FDA.