Cleared Traditional

A HOOK DRIVER

K820660 · Twin City Surgical, Inc. · Orthopedic
Mar 1982
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K820660 is an FDA 510(k) clearance for the A HOOK DRIVER, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Twin City Surgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1982, 9 days after receiving the submission on March 10, 1982. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K820660 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1982
Decision Date March 19, 1982
Days to Decision 9 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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