FDA 510(k)

OS2(R)-VP Varisation Staple

K-Number: K153770 · 2016-03-21

Decision Date2016-03-21

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OS2(R)-VP Varisation Staple is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2016-03-21 under approval number K153770. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OS2(R)-VP Varisation Staple?

OS2(R)-VP Varisation Staple is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by In2bones Sas. The 510(k) number is K153770.

When was OS2(R)-VP Varisation Staple approved by the FDA?

OS2(R)-VP Varisation Staple received FDA 510(k) clearance on 2016-03-21, under approval number K153770.

What company makes OS2(R)-VP Varisation Staple?

OS2(R)-VP Varisation Staple is manufactured by In2bones Sas.

What is the FDA product code for OS2(R)-VP Varisation Staple?

The FDA product code for OS2(R)-VP Varisation Staple is JDR.

Other Devices by In2bones Sas

K160174I.B.S. 2.0 Osteosynthesis screw K160995NEOVIEW Plating System K153395OS2-C Compression Staple K153204In2Bones Kirschner wire K170688PITStop® implant K173121Ankle Fusion Plating System

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Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp. K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.

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.