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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 the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-02-18 under 510(k) 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. The listed applicant is In2bones Sas. The 510(k) number is K153395.

When did OS2-C Compression Staple receive FDA 510(k) clearance?

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

Who is the listed applicant for OS2-C Compression Staple?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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