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FDA 510(k)

Mako Total Hip Application 5.0

K-Number: K243751 · 2025-03-05

ApplicantMako Surgical Corp.
Decision Date2025-03-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mako Total Hip Application 5.0 is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2025-03-05 under approval number K243751. 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 5.0?

Mako Total Hip Application 5.0 is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Mako Surgical Corp.. The 510(k) number is K243751.

When was Mako Total Hip Application 5.0 approved by the FDA?

Mako Total Hip Application 5.0 received FDA 510(k) clearance on 2025-03-05, under approval number K243751.

What company makes Mako Total Hip Application 5.0?

Mako Total Hip Application 5.0 is manufactured by Mako Surgical Corp..

What is the FDA product code for Mako Total Hip Application 5.0?

The FDA product code for Mako Total Hip Application 5.0 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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