Cleared Traditional

K894228 - KRONNER SPHERICAL CUTTERS
(FDA 510(k) Clearance)

K894228 · Kronner Medical · Orthopedic device

Jul 1990

Decision

399d

Days

Class 1

Risk

K894228 is an FDA 510(k) clearance for the KRONNER SPHERICAL CUTTERS. This device is classified as a Template (Class I - General Controls, product code HWT).

Submitted by Kronner Medical (Roseburg, US). The FDA issued a Cleared decision on July 23, 1990, 399 days after receiving the submission on June 19, 1989.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4800.

Submission Details

510(k) Number	K894228 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 1989
Decision Date	July 23, 1990
Days to Decision	399 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—