510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K892638Substantially Equivalent

Tracer Dynamic Axial Fixation

Tracer Medical, Santa Paula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892638 is the FDA 510(k) clearance record for TRACER DYNAMIC AXIAL FIXATION, a class II device, cleared for Tracer Medical on under FDA product code JEC (Component, Traction, Invasive). FDA records list one 510(k) clearance for Tracer Medical. As of , FDA records show no recalls naming K892638.

Clearance record

Decision date
Received
(121 days to decision)
Product code
JEC Component, Traction, Invasive
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Tracer Medical 333 S. 11th St., Santa Paula CA
Third party review
No

Clearances, product code JEC

Trailing 12 months

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

FDA records show no clearances under product code JEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEC, 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