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FDA 510(k)

Mako Shoulder Application (1.0)

K-Number: K242373 · 2024-11-07

ApplicantMako Surgical Corp.
Decision Date2024-11-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mako Shoulder Application (1.0) is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2024-11-07 under approval number K242373. 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 Shoulder Application (1.0)?

Mako Shoulder Application (1.0) is a medical device that received FDA 510(k) clearance on 2024-11-07. It is manufactured by Mako Surgical Corp.. The 510(k) number is K242373.

When was Mako Shoulder Application (1.0) approved by the FDA?

Mako Shoulder Application (1.0) received FDA 510(k) clearance on 2024-11-07, under approval number K242373.

What company makes Mako Shoulder Application (1.0)?

Mako Shoulder Application (1.0) is manufactured by Mako Surgical Corp..

What is the FDA product code for Mako Shoulder Application (1.0)?

The FDA product code for Mako Shoulder Application (1.0) is OLO.

Related Clinical Trials

NCT04068454 Virtual Reality in Reeducation : Application to Shoulder Affections TERMINATED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT07495254 Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy NOT_YET_RECRUITING

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 →

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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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