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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 the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) 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. The listed applicant is Mako Surgical Corp.. The 510(k) number is K250608.

When did Mako Total Knee Application (3.0); Hybrid Tip Pointer receive FDA 510(k) clearance?

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

Who is the listed applicant for Mako Total Knee Application (3.0); Hybrid Tip Pointer?

The FDA 510(k) record lists Mako Surgical Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Mako Surgical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260222Mako Total Knee ApplicationK243751Mako Total Hip Application 5.0K242373Mako Shoulder Application (1.0)K241011Mako Total Knee ApplicationK220930Restoris Multi-Compartmental Knee SystemK220459Mako Total Knee Application

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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