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Bryan Spinal Fixater (BSF)

by Arcan Orthopaedic Corp.

510(k) K914548

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)SN Traditional NumberK914548 Date28 Mar 1994DecidedStatusActive

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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 19 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 Bryan Spinal Fixater (BSF) is a spinal fixation device designed for internal orthopedic stabilization of the spine. It is classified under the nomenclature for orthopedic fixation devices and is intended for use in surgical procedures requiring rigid support to correct spinal deformities or injuries, such as scoliosis, fractures, or severe spondylolisthesis.

This device is supplied sterile and intended for single-use, though reuse may be considered under controlled conditions as specified by the manufacturer. It is regulated under the FDA’s 510(k) clearance pathway (K914548) and falls under the Traditional review process for orthopedic devices. The BSF is supplied in a sterile package and must be handled according to aseptic techniques prior to surgical use.

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