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FDA 510(k)

Kleiner KG2 System

K-Number: K211474 · 2021-09-14

ApplicantBAAT Medical Products B.V.
Decision Date2021-09-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kleiner KG2 System 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 2021-09-14 under 510(k) number K211474. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kleiner KG2 System?

Kleiner KG2 System is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K211474.

When did Kleiner KG2 System receive FDA 510(k) clearance?

Kleiner KG2 System received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211474.

Who is the listed applicant for Kleiner KG2 System?

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 Kleiner KG2 System?

The FDA product code for Kleiner KG2 System is MAX.

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 RodK220966SINEFIXK201830ANSER Clavicle Pin

Related Devices (Code: MAX)

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Official Source

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

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