Cleared Traditional

K843368 - KAPP SPINAL BUTTON (FDA 510(k) Clearance)

K843368 · Kapp Surgical Instrument, Inc. · Orthopedic device

Sep 1984

Decision

15d

Days

Class 2

Risk

K843368 is an FDA 510(k) clearance for the KAPP SPINAL BUTTON. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by Kapp Surgical Instrument, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984, 15 days after receiving the submission on August 28, 1984.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K843368 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1984
Decision Date	September 12, 1984
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	-