510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803031Substantially Equivalent

Laure Wrist Implant

Laure Prosthetics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803031 is the FDA 510(k) clearance record for LAURE WRIST IMPLANT, a class II device, cleared for Laure Prosthetics, Inc. on under FDA product code KWM (Prosthesis, Wrist, Semi-Constrained). FDA records list one 510(k) clearance for Laure Prosthetics, Inc. As of , FDA records show no recalls naming K803031.

Clearance record

Decision date
Received
(578 days to decision)
Product code
KWM Prosthesis, Wrist, Semi-Constrained
Regulation
21 CFR 888.3800
Device class
Class II
Review panel
Orthopedic
Applicant
Laure Prosthetics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KWM

Trailing 12 months

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

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