510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864403Substantially Equivalent

Monticelli Spinelli External Fixation System

Howmedica Corp., Rutherford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864403 is the FDA 510(k) clearance record for MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM, a class II device, cleared for Howmedica Corp. on under FDA product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite). FDA records list 409 510(k) clearances for Howmedica Corp., from to . As of , FDA records show no recalls naming K864403.

Clearance record

Decision date
Received
(38 days to decision)
Product code
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Corp. 359 Veterans Blvd., Rutherford NJ
Third party review
No

Clearances, product code LXT

Trailing 12 months

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

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