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FDA 510(k)

Mako Total Hip Application, Mako Total Knee Application

K-Number: K191998 · 2019-09-24

ApplicantMako Surgical Corp.
Decision Date2019-09-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mako Total Hip Application, Mako Total Knee Application is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2019-09-24 under approval number K191998. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mako Total Hip Application, Mako Total Knee Application?

Mako Total Hip Application, Mako Total Knee Application is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Mako Surgical Corp.. The 510(k) number is K191998.

When was Mako Total Hip Application, Mako Total Knee Application approved by the FDA?

Mako Total Hip Application, Mako Total Knee Application received FDA 510(k) clearance on 2019-09-24, under approval number K191998.

What company makes Mako Total Hip Application, Mako Total Knee Application?

Mako Total Hip Application, Mako Total Knee Application is manufactured by Mako Surgical Corp..

What is the FDA product code for Mako Total Hip Application, Mako Total Knee Application?

The FDA product code for Mako Total Hip Application, Mako Total Knee Application is OLO.

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Related PubMed Literature

PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Mako Surgical Corp.

K172301Mako Partial Knee Application K172219Mako Total Knee Application K170891Mako Partial Knee Application K170584Mako Partial Knee Application K170581Mako Total Knee Application K170593Mako Total Hip Application

View all 16 devices →

Related Devices (Code: OLO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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