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FDA 510(k)

ActivaScrew™ Cannulated COM

K-Number: K261057 · 2026-09-04

ApplicantBioretec, Ltd.
Decision Date2026-09-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ActivaScrew™ Cannulated COM is the device name listed in this FDA 510(k) record. The listed applicant is Bioretec, Ltd.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K261057. 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 ActivaScrew™ Cannulated COM?

ActivaScrew™ Cannulated COM is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Bioretec, Ltd.. The 510(k) number is K261057.

When did ActivaScrew™ Cannulated COM receive FDA 510(k) clearance?

ActivaScrew™ Cannulated COM received FDA 510(k) clearance on 2026-09-04, under 510(k) number K261057.

Who is the listed applicant for ActivaScrew™ Cannulated COM?

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

What is the FDA product code for ActivaScrew™ Cannulated COM?

The FDA product code for ActivaScrew™ Cannulated COM 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.

K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large 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 Ortho

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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