Cleared Traditional

K864422 - RAYLOR(TM) MALLET
(FDA 510(k) Clearance)

K864422 · Cedar Surgical, Inc. · Orthopedic device

Nov 1986

Decision

14d

Days

Class 1

Risk

K864422 is an FDA 510(k) clearance for the RAYLOR(TM) MALLET. This device is classified as a Impactor (Class I - General Controls, product code HWA).

Submitted by Cedar Surgical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 24, 1986, 14 days after receiving the submission on November 10, 1986.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K864422 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 10, 1986
Decision Date	November 24, 1986
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—