Cleared Traditional

SWANSON TITANIUM CARPAL LUNATE IMPLANT

K864491 · Dow Corning Wright · Orthopedic
Apr 1987
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K864491 is an FDA 510(k) clearance for the SWANSON TITANIUM CARPAL LUNATE IMPLANT, a Prosthesis, Wrist, Carpal Lunate (Class II — Special Controls, product code KWN), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on April 15, 1987, 153 days after receiving the submission on November 13, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3750.

Submission Details

510(k) Number K864491 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1986
Decision Date April 15, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWN — Prosthesis, Wrist, Carpal Lunate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3750