510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101375Substantially Equivalent

Trimed X-Fix

Trimed Inc, Saugus CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101375 is the FDA 510(k) clearance record for TRIMED X-FIX, a class II device, cleared for TriMed, Inc. on under FDA product code NDK (System, External Fixator (With Metallic Invasive Components)). FDA records list 38 510(k) clearances for TriMed, Inc., from to . As of , FDA records show no recalls naming K101375.

Clearance record

Decision date
Received
(121 days to decision)
Product code
NDK System, External Fixator (With Metallic Invasive Components)
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
TriMed, Inc. 28337 Maitland Ln., Saugus CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDK

Trailing 12 months

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

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