Cleared Traditional

ANSER Clavicle Pin

K201830 · BAAT Medical Products B.V. · Orthopedic

Aug 2020

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K201830 is an FDA 510(k) clearance for the ANSER Clavicle Pin, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by BAAT Medical Products B.V. (Rj Hengelo, NL). The FDA issued a Cleared decision on August 27, 2020, 56 days after receiving the submission on July 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K201830 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2020
Decision Date	August 27, 2020
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF