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FDA 510(k)

CoLink® & CoLag® Non-Sterile Screws

K-Number: K261154 · 2026-05-30

ApplicantIn2Bones USA, LLC
Decision Date2026-05-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink® & CoLag® Non-Sterile Screws is the device name listed in this FDA 510(k) record. The listed applicant is In2Bones USA, LLC. It received FDA 510(k) clearance on 2026-05-30 under 510(k) number K261154. 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 CoLink® & CoLag® Non-Sterile Screws?

CoLink® & CoLag® Non-Sterile Screws is a medical device that received FDA 510(k) clearance on 2026-05-30. The listed applicant is In2Bones USA, LLC. The 510(k) number is K261154.

When did CoLink® & CoLag® Non-Sterile Screws receive FDA 510(k) clearance?

CoLink® & CoLag® Non-Sterile Screws received FDA 510(k) clearance on 2026-05-30, under 510(k) number K261154.

Who is the listed applicant for CoLink® & CoLag® Non-Sterile Screws?

The FDA 510(k) record lists In2Bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink® & CoLag® Non-Sterile Screws?

The FDA product code for CoLink® & CoLag® Non-Sterile Screws is HWC. This falls under the Cardiovascular category.

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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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