Cleared Traditional

M.W.P. WRIST PROSTHESIS

K872502 · Protek, Inc. · Orthopedic
Jul 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K872502 is an FDA 510(k) clearance for the M.W.P. WRIST PROSTHESIS, a Prosthesis, Wrist, Semi-constrained (Class II — Special Controls, product code KWM), submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 23, 1987, 29 days after receiving the submission on June 24, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number K872502 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1987
Decision Date July 23, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWM — Prosthesis, Wrist, Semi-constrained
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3800