Cleared Traditional

K851786 - 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
(FDA 510(k) Clearance)

K851786 · Artiberia · Orthopedic
Jul 1985
Decision
75d
Days
Class 1
Risk

K851786 is an FDA 510(k) clearance for the 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF. This device is classified as a Instrument, Cast Application/removal, Manual (Class I — General Controls, product code LGG).

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 9, 1985, 75 days after receiving the submission on April 25, 1985.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5980.

Submission Details

510(k) Number K851786 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1985
Decision Date July 09, 1985
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LGG — Instrument, Cast Application/removal, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5980