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FDA 510(k)

OS2-C Compression Staple

K-Number: K153395 · 2016-02-18

ApplicantIn2bones Sas
Decision Date2016-02-18
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OS2-C Compression Staple is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2016-02-18 under approval number K153395. 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-C Compression Staple?

OS2-C Compression Staple is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by In2bones Sas. The 510(k) number is K153395.

When was OS2-C Compression Staple approved by the FDA?

OS2-C Compression Staple received FDA 510(k) clearance on 2016-02-18, under approval number K153395.

What company makes OS2-C Compression Staple?

OS2-C Compression Staple is manufactured by In2bones Sas.

What is the FDA product code for OS2-C Compression Staple?

The FDA product code for OS2-C Compression Staple is JDR.

Other Devices by In2bones Sas

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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 K153770OS2(R)-VP Varisation 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.

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