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FDA 510(k)

Intai Anatomic Locking Plate and Screw System

K-Number: K201229 · 2022-03-11

ApplicantIntai Technology Corporation
Decision Date2022-03-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intai Anatomic Locking Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corporation. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K201229. 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 Intai Anatomic Locking Plate and Screw System?

Intai Anatomic Locking Plate and Screw System is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Intai Technology Corporation. The 510(k) number is K201229.

When did Intai Anatomic Locking Plate and Screw System receive FDA 510(k) clearance?

Intai Anatomic Locking Plate and Screw System received FDA 510(k) clearance on 2022-03-11, under 510(k) number K201229.

Who is the listed applicant for Intai Anatomic Locking Plate and Screw System?

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

What is the FDA product code for Intai Anatomic Locking Plate and Screw System?

The FDA product code for Intai Anatomic Locking Plate and Screw System is HRS.

Other records listing Intai Technology Corporation 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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