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FDA 510(k)

Stealth Staple System

K-Number: K163440 · 2017-02-01

ApplicantFirst Ray, LLC
Decision Date2017-02-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stealth Staple System is a medical device manufactured by First Ray, LLC. It received FDA 510(k) clearance on 2017-02-01 under approval number K163440. 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 Stealth Staple System?

Stealth Staple System is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by First Ray, LLC. The 510(k) number is K163440.

When was Stealth Staple System approved by the FDA?

Stealth Staple System received FDA 510(k) clearance on 2017-02-01, under approval number K163440.

What company makes Stealth Staple System?

Stealth Staple System is manufactured by First Ray, LLC.

What is the FDA product code for Stealth Staple System?

The FDA product code for Stealth Staple System is JDR.

Other Devices by First Ray, LLC

K153585Flip Button Suture Anchor K153638Bicortical Fixation Screw & Washer Nut System K153622First Ray Internal Bone Staple System

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 K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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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