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FDA 510(k)

Bolo Button System

K-Number: K242091 · 2024-12-23

ApplicantFusion Orthopedics
Decision Date2024-12-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bolo Button System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K242091. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bolo Button System?

Bolo Button System is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Fusion Orthopedics. The 510(k) number is K242091.

When did Bolo Button System receive FDA 510(k) clearance?

Bolo Button System received FDA 510(k) clearance on 2024-12-23, under 510(k) number K242091.

Who is the listed applicant for Bolo Button System?

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

What is the FDA product code for Bolo Button System?

The FDA product code for Bolo Button System is HTN.

Other records listing Fusion Orthopedics as applicant

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Related Devices (Code: HTN)

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.

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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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