510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140649Substantially Equivalent

Vectrix External Fixator

3D Medical Concepts, LLC, Pelham AL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140649 is the FDA 510(k) clearance record for VECTRIX EXTERNAL FIXATOR, a class II device, cleared for 3D Medical Concepts, LLC on under FDA product code NDK (System, External Fixator (With Metallic Invasive Components)). FDA records list one 510(k) clearance for 3D Medical Concepts, LLC. As of , FDA records show no recalls naming K140649.

Clearance record

Decision date
Received
(291 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
3D Medical Concepts, LLC 1061 Morgan Park Rd., Pelham AL
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