510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843554Substantially Equivalent

Bone Screws

Mecron Medical Products, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843554 is the FDA 510(k) clearance record for BONE SCREWS, a class II device, cleared for Mecron Medical Products, Inc. on under FDA product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component). FDA records list 14 510(k) clearances for Mecron Medical Products, Inc., from to . As of , FDA records show no recalls naming K843554.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Mecron Medical Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KTW

Trailing 12 months

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

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