Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANSER Clavicle Pin

K-Number: K201830 · 2020-08-27

ApplicantBAAT Medical Products B.V.
Decision Date2020-08-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANSER Clavicle Pin is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K201830. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSER Clavicle Pin?

ANSER Clavicle Pin is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K201830.

When did ANSER Clavicle Pin receive FDA 510(k) clearance?

ANSER Clavicle Pin received FDA 510(k) clearance on 2020-08-27, under 510(k) number K201830.

Who is the listed applicant for ANSER Clavicle Pin?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANSER Clavicle Pin?

The FDA product code for ANSER Clavicle Pin is HSB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05721560SINEFIX-2022 Pilot PhaseACTIVE_NOT_RECRUITINGNCT06818448SINEFIX-2022 Comparative PhaseRECRUITING

Other records listing BAAT Medical Products B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254176SINEFIXK251961SDS Growing RodK220966SINEFIXK211474Kleiner KG2 System

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑