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FDA 510(k)

Airlock Centrolock Osteosynthesis Implant System

K-Number: K192356 · 2019-12-14

ApplicantNovastep
Decision Date2019-12-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Airlock Centrolock Osteosynthesis Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Novastep. It received FDA 510(k) clearance on 2019-12-14 under 510(k) number K192356. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Airlock Centrolock Osteosynthesis Implant System?

Airlock Centrolock Osteosynthesis Implant System is a medical device that received FDA 510(k) clearance on 2019-12-14. The listed applicant is Novastep. The 510(k) number is K192356.

When did Airlock Centrolock Osteosynthesis Implant System receive FDA 510(k) clearance?

Airlock Centrolock Osteosynthesis Implant System received FDA 510(k) clearance on 2019-12-14, under 510(k) number K192356.

Who is the listed applicant for Airlock Centrolock Osteosynthesis Implant System?

The FDA 510(k) record lists Novastep as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airlock Centrolock Osteosynthesis Implant System?

The FDA product code for Airlock Centrolock Osteosynthesis Implant System is HRS.

Other records listing Novastep 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.

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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