Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OsteoCoil™ GT Active Compression System

K-Number: K260106 · 2026-08-24

ApplicantFlower Orthopedics Corporation DBA Conventus Flower Orthoped
Decision Date2026-08-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.

↑