510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864746Substantially Equivalent

Bremer Halo System

Bremer Orthopedics, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864746 is the FDA 510(k) clearance record for BREMER HALO SYSTEM, a class II device, cleared for Bremer Orthopedics on under FDA product code HAX (Tong, Skull For Traction). FDA records list one 510(k) clearance for Bremer Orthopedics. As of , FDA records show no recalls naming K864746.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HAX Tong, Skull For Traction
Regulation
21 CFR 882.5960
Device class
Class II
Review panel
Neurology
Applicant
Bremer Orthopedics 433 Margaret St., Jacksonville FL
Third party review
No

Clearances, product code HAX

Trailing 12 months

FDA records hold no clearances under product code HAX in the trailing twelve months.

FDA records show no clearances under product code HAX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HAX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260