510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851786Substantially Equivalent

27-230 to 27-234 Various Cast Breakers, Wolf

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

K851786 is the FDA 510(k) clearance record for 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF, a class I device, cleared for Artiberia on under FDA product code LGG (Instrument, Cast Application/Removal, Manual). FDA records list 79 510(k) clearances for Artiberia, from to . As of , FDA records show no recalls naming K851786.

Clearance record

Decision date
Received
(75 days to decision)
Product code
LGG Instrument, Cast Application/Removal, Manual
Regulation
21 CFR 888.5980
Device class
Class I
Review panel
Orthopedic
Applicant
Artiberia 4518 Los Ranchitos, San Antonio TX
Third party review
No

Clearances, product code LGG

Trailing 12 months

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

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