510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K882349Substantially Equivalent

Mallet, Surgical

Treace Medical, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882349 is the FDA 510(k) clearance record for MALLET, SURGICAL, a class I device, cleared for Treace Medical, Inc. on under FDA product code HXL (Mallet). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K882349.

Clearance record

Decision date
Received
(16 days to decision)
Product code
HXL Mallet
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Treace Medical, Inc. Suite 400, Memphis TN
Third party review
No

Clearances, product code HXL

Trailing 12 months

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

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