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FDA 510(k)

Forma Medical Optimal Plating System

K-Number: K234059 · 2024-06-26

ApplicantForma Medical, Inc.
Decision Date2024-06-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Forma Medical Optimal Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Forma Medical, Inc.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K234059. 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 Forma Medical Optimal Plating System?

Forma Medical Optimal Plating System is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Forma Medical, Inc.. The 510(k) number is K234059.

When did Forma Medical Optimal Plating System receive FDA 510(k) clearance?

Forma Medical Optimal Plating System received FDA 510(k) clearance on 2024-06-26, under 510(k) number K234059.

Who is the listed applicant for Forma Medical Optimal Plating System?

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

What is the FDA product code for Forma Medical Optimal Plating System?

The FDA product code for Forma Medical Optimal Plating System is HRS.

Other records listing Forma Medical, Inc. 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.

K230945Forma Medical Headless Compression Screw

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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