First Ray Internal Bone Staple System

FDA 510(k) K153622 · First Ray, LLC

Substantially Equivalent

510(k) numberK153622

Submission

Device name
First Ray Internal Bone Staple System
Applicant
First Ray, LLC
Logan, UT, US
Received
December 18, 2015
Decision date
April 8, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDR – Staple, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K242415TMC Compression Implant SystemJDR · Special Treace Medical Concepts09/06/2024SE
K240212COGNiTiON™ Staple SystemJDR · Special Ortho Solutions UK , Ltd.02/23/2024SE
K232990A’TOMIC™ Nitinol Fixation SystemJDR · Traditional Rmr Ortho, LLC01/12/2024SE
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional Novastep12/04/2023SE

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K163440Stealth Staple SystemJDR · Traditional 02/01/2017SE
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Questions and answers

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

First Ray Internal Bone Staple System (K153622) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 112 days after the submission was received.

What is the product code of K153622?

The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.