ANSER Clavicle Pin

FDA 510(k) K201830 · BAAT Medical Products B.V.

Substantially Equivalent

510(k) numberK201830

Submission

Device name
ANSER Clavicle Pin
Applicant
BAAT Medical Products B.V.
Rj Hengelo, NL
Received
July 2, 2020
Decision date
August 27, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
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Questions and answers

When was ANSER Clavicle Pin cleared by the FDA?

ANSER Clavicle Pin (K201830) received a 510(k) decision of Substantially Equivalent on August 27, 2020, 56 days after the submission was received.

What is the product code of K201830?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.