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FDA 510(k)

Mako Total Knee Application (3.0); Hybrid Tip Pointer

K-Number: K250608 · 2025-04-25

ApplicantMako Surgical Corp.
Decision Date2025-04-25
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mako Total Knee Application (3.0); Hybrid Tip Pointer is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2025-04-25 under approval number K250608. 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 Knee Application (3.0); Hybrid Tip Pointer?

Mako Total Knee Application (3.0); Hybrid Tip Pointer is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Mako Surgical Corp.. The 510(k) number is K250608.

When was Mako Total Knee Application (3.0); Hybrid Tip Pointer approved by the FDA?

Mako Total Knee Application (3.0); Hybrid Tip Pointer received FDA 510(k) clearance on 2025-04-25, under approval number K250608.

What company makes Mako Total Knee Application (3.0); Hybrid Tip Pointer?

Mako Total Knee Application (3.0); Hybrid Tip Pointer is manufactured by Mako Surgical Corp..

What is the FDA product code for Mako Total Knee Application (3.0); Hybrid Tip Pointer?

The FDA product code for Mako Total Knee Application (3.0); Hybrid Tip Pointer 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) PMID: 33125510 Effectiveness of vibrational forces on orthodontic treatment : A randomized, controlled clinical trial. Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie (2021)

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)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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