Cleared Traditional

SPINAL WRENCH

K813067 · Twin City Surgical, Inc. · Orthopedic
Nov 1981
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K813067 is an FDA 510(k) clearance for the SPINAL WRENCH, a Wrench (Class I — General Controls, product code HXC), submitted by Twin City Surgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981, 25 days after receiving the submission on October 30, 1981. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K813067 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1981
Decision Date November 24, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HXC — Wrench
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540