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First Ray Internal Bone Staple System

by First Ray, LLC

510(k) K153622

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153622 Date8 Apr 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The First Ray Internal Bone Staple System is an orthopedic implant designed to fix bone fractures, osteotomies, and achieve joint fusion. The system consists of metallic staples and screws that engage two bone fragments, holding them in close apposition to facilitate healing. It is indicated for fixation of bone fractures, fusions, or for bone reconstructions.

The system is supplied for use in orthopedic procedures, including arthrodesis in hand or foot surgery, mono or bi-cortical osteotomies, fracture management, and distal or proximal metatarsal or metacarpal osteotomies. The device received FDA 510(k) clearance under approval number K153622.

Other devices from First Ray, LLC

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the First Ray Internal Bone Staple System used for?

    The First Ray Internal Bone Staple System is used for fixation of bone fractures, fusions, or for bone reconstructions, including arthrodesis in hand or foot surgery and osteotomies.

  • Is the First Ray Internal Bone Staple System supplied sterile?

    The description does not specify if the system is supplied sterile, but it is designed for use in orthopedic procedures where sterility is typically required.

  • What is the regulatory status of the First Ray Internal Bone Staple System?

    The device received FDA 510(k) clearance under approval number K153622, indicating it is substantially equivalent to a predicate device.

  • What types of procedures can the First Ray Internal Bone Staple System be used for?

    The system can be used for various orthopedic procedures, including mono or bi-cortical osteotomies, fracture management, and distal or proximal metatarsal or metacarpal osteotomies.