510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954069Substantially Equivalent

Ace Cervical Traction Halozs, Tongs & Pins

Ace Medical, El Segundo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954069 is the FDA 510(k) clearance record for ACE CERVICAL TRACTION HALOZS, TONGS & PINS, a class II device, cleared for Ace Medical Co. on under FDA product code HAX (Tong, Skull For Traction). FDA records list 22 510(k) clearances for Ace Medical Co., from to . As of , FDA records show no recalls naming K954069.

Clearance record

Decision date
Received
(43 days to decision)
Product code
HAX Tong, Skull For Traction
Regulation
21 CFR 882.5960
Device class
Class II
Review panel
Neurology
Applicant
Ace Medical Co. 2260 E. El Segundo Blvd., El Segundo CA
510(k) summary
Summary
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