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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 the device name listed in this FDA 510(k) record. The listed applicant is First Ray, LLC. It received FDA 510(k) clearance on 2016-04-08 under 510(k) 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. The listed applicant is First Ray, LLC. The 510(k) number is K153622.

When did First Ray Internal Bone Staple System receive FDA 510(k) clearance?

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

Who is the listed applicant for First Ray Internal Bone Staple System?

The FDA 510(k) record lists First Ray, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing First Ray, LLC as applicant

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.

K163440Stealth Staple SystemK153585Flip Button Suture AnchorK153638Bicortical Fixation Screw & Washer Nut System

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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