Cleared Traditional

AMC R METACARPAL COMPONENT

K790793 · Howmedica Corp. · Orthopedic
Jun 1979
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K790793 is an FDA 510(k) clearance for the AMC R METACARPAL COMPONENT, a Prosthesis, Wrist, Carpal Lunate (Class II — Special Controls, product code KWN), submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1979, 59 days after receiving the submission on April 24, 1979. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3750.

Submission Details

510(k) Number K790793 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1979
Decision Date June 22, 1979
Days to Decision 59 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