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FDA 510(k)

OsteoCoil™ GT Active Compression System

Número K: K260106 · 2026-08-24

RequerenteFlower Orthopedics Corporation DBA Conventus Flower Orthoped
Data da decisão2026-08-24
Código do produtoHWC
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoCoil™ GT Active Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation DBA Conventus Flower Orthoped. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K260106. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OsteoCoil™ GT Active Compression System?

OsteoCoil™ GT Active Compression System is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is Flower Orthopedics Corporation DBA Conventus Flower Orthoped. The 510(k) number is K260106.

When did OsteoCoil™ GT Active Compression System receive FDA 510(k) clearance?

OsteoCoil™ GT Active Compression System received FDA 510(k) clearance on 2026-08-24, under 510(k) number K260106.

Who is the listed applicant for OsteoCoil™ GT Active Compression System?

The FDA 510(k) record lists Flower Orthopedics Corporation DBA Conventus Flower Orthoped as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCoil™ GT Active Compression System?

The FDA product code for OsteoCoil™ GT Active Compression System is HWC. This falls under the Cardiovascular category.

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