510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800602Substantially Equivalent

Taleisnik Total Wrist Prosthesis

Dow Corning Wright, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800602 is the FDA 510(k) clearance record for TALEISNIK TOTAL WRIST PROSTHESIS, a class II device, cleared for Dow Corning Wright on under FDA product code KWM (Prosthesis, Wrist, Semi-Constrained). FDA records list 74 510(k) clearances for Dow Corning Wright, from to . As of , FDA records show no recalls naming K800602.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KWM Prosthesis, Wrist, Semi-Constrained
Regulation
21 CFR 888.3800
Device class
Class II
Review panel
Orthopedic
Applicant
Dow Corning Wright 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