510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851789Substantially Equivalent

29-200 to 29-230 Various Bone Mallets(wihiger, Doy

Artiberia, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851789 is the FDA 510(k) clearance record for 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY, a class I device, cleared for Artiberia on under FDA product code GFJ (Mallet, Surgical, General & Plastic Surgery). FDA records list 79 510(k) clearances for Artiberia, from to . As of , FDA records show no recalls naming K851789.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GFJ Mallet, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Artiberia 4518 Los Ranchitos, San Antonio TX
Third party review
No

Clearances, product code GFJ

Trailing 12 months

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

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