BREMER HALO SYSTEM— 510(k) K864746

Substantially Equivalent

Bremer Orthopedics

FDA 510(k) clearance K864746 for BREMER HALO SYSTEM, Substantially Equivalent on 1986-12-22. Applicant: Bremer Orthopedics. Device class: 2.

Clearance details

Applicant: Bremer Orthopedics
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 1986-12-05
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAX

K090733 — PMT HALO SYSTEM2009-07-28
K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D2007-05-25
K051918 — RESOLVE OPEN BACK HALO RINGS2005-08-17
K023959 — JEROME GLASS RING2003-02-21
K003662 — SPINE WORKS COLLAR2001-07-09

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