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)

OSSIOfiber Compression Screw, 3.5mm

K-Number: K213596 · 2021-12-21

ApplicantOSSIO , Ltd.
Decision Date2021-12-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber Compression Screw, 3.5mm is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213596. 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 OSSIOfiber Compression Screw, 3.5mm?

OSSIOfiber Compression Screw, 3.5mm is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is OSSIO , Ltd.. The 510(k) number is K213596.

When did OSSIOfiber Compression Screw, 3.5mm receive FDA 510(k) clearance?

OSSIOfiber Compression Screw, 3.5mm received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213596.

Who is the listed applicant for OSSIOfiber Compression Screw, 3.5mm?

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

What is the FDA product code for OSSIOfiber Compression Screw, 3.5mm?

The FDA product code for OSSIOfiber Compression Screw, 3.5mm is HWC. This falls under the Cardiovascular category.

Other records listing OSSIO , Ltd. as applicant

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.

K254077OSSIOfiber® Threaded Trimmable Fixation NailK254055OSSIOfiber® Suture AnchorK252022OSSIOfiber® Interference ScrewK251309OSSIOfiber® Suture AnchorK243760OSSIOfiber® Suture Anchor 2.5-3.5 mmK241932OSSIOfiber® Compression Staple

View all 20 devices →

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.

↑