FDA 510(k)

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

K-Nummer: K231272 · 2023-12-01

Entscheidungsdatum2023-12-01

ProduktcodeHTY

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231272. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is OSSIO , Ltd.. The 510(k) number is K231272.

When did OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail receive FDA 510(k) clearance?

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231272.

Who is the listed applicant for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

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® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail?

The FDA product code for OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail is HTY.

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Weitere Einträge mit OSSIO , Ltd. als Antragsteller

K254077OSSIOfiber® Threaded Trimmable Fixation Nail K254055OSSIOfiber® Suture Anchor K252022OSSIOfiber® Interference Screw K251309OSSIOfiber® Suture Anchor K243760OSSIOfiber® Suture Anchor 2.5-3.5 mm K241932OSSIOfiber® Compression Staple

Alle 20 Geräte anzeigen →

Verwandte Geräte (Code: HTY)

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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