Anjon Bremer Halo System— 510(k) K193256

Substantially Equivalent

Anjon Holdings, LLC

FDA 510(k) clearance K193256 for Anjon Bremer Halo System, Substantially Equivalent on 2020-03-02. Applicant: Anjon Holdings, LLC. Device class: 2.

Clearance details

Applicant: Anjon Holdings, LLC
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2019-11-26
Decision date: 2020-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JEC

K203605 — SteriTrak2021-04-23
K192465 — DigiFix Sterile Kit2019-10-10
K181192 — PIP Fix2018-10-22
K171863 — Anjon Bremer Halo System2018-03-19
K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices2016-12-28

Recalls naming K193256

K-number listed on FDA's recall record

Z-2778-2020 — Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.Class II·Terminated·Anjon Holdings·20200618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193256.

Data sourced from openFDA. This site is unofficial and independent of the FDA.