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FDA 510(k)

First Ray Internal Bone Staple System

K-Number: K153622 · 2016-04-08

ApplicantFirst Ray, LLC
Decision Date2016-04-08
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

First Ray Internal Bone Staple System is a medical device manufactured by First Ray, LLC. It received FDA 510(k) clearance on 2016-04-08 under approval number K153622. 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 First Ray Internal Bone Staple System?

First Ray Internal Bone Staple System is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by First Ray, LLC. The 510(k) number is K153622.

When was First Ray Internal Bone Staple System approved by the FDA?

First Ray Internal Bone Staple System received FDA 510(k) clearance on 2016-04-08, under approval number K153622.

What company makes First Ray Internal Bone Staple System?

First Ray Internal Bone Staple System is manufactured by First Ray, LLC.

What is the FDA product code for First Ray Internal Bone Staple System?

The FDA product code for First Ray Internal Bone Staple System is JDR.

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Related PubMed Literature

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Other Devices by First Ray, LLC

K153585Flip Button Suture Anchor K153638Bicortical Fixation Screw & Washer Nut System K163440Stealth Staple System

Related Devices (Code: JDR)

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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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