Cleared Traditional

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY

K943873 · Orthomet, Inc. · Orthopedic
Apr 1995
Decision
260d
Days
Class 1
Risk

About This 510(k) Submission

K943873 is an FDA 510(k) clearance for the ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 26, 1995, 260 days after receiving the submission on August 9, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K943873 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1994
Decision Date April 26, 1995
Days to Decision 260 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LXH — Orthopedic Manual Surgical Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540