Cleared Traditional

K200701 - Skeletal Dynamics Midshaft Humerus Plating System
(FDA 510(k) Clearance)

K200701 · Skeletal Dynamics, Inc. · Orthopedic

May 2020

Decision

57d

Days

Class 2

Risk

K200701 is an FDA 510(k) clearance for the Skeletal Dynamics Midshaft Humerus Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on May 14, 2020, 57 days after receiving the submission on March 18, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K200701 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2020
Decision Date	May 14, 2020
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF