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FDA 510(k)

BPS - Bone Fragment Fixation Plates, Screws and Washers

K-Number: K250055 · 2025-02-06

ApplicantOrthonovis, Inc.
Decision Date2025-02-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BPS - Bone Fragment Fixation Plates, Screws and Washers is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K250055. 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 BPS - Bone Fragment Fixation Plates, Screws and Washers?

BPS - Bone Fragment Fixation Plates, Screws and Washers is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Orthonovis, Inc.. The 510(k) number is K250055.

When did BPS - Bone Fragment Fixation Plates, Screws and Washers receive FDA 510(k) clearance?

BPS - Bone Fragment Fixation Plates, Screws and Washers received FDA 510(k) clearance on 2025-02-06, under 510(k) number K250055.

Who is the listed applicant for BPS - Bone Fragment Fixation Plates, Screws and Washers?

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

What is the FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers?

The FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers is HRS.

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.

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Other records listing Orthonovis, 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.

K252758Cannulated Screw and Kirschner (K wire) SystemK250498BPS Wrist Fracture SystemK242343BPS Wrist Fracture SystemK213905ONX Large External Fixation System

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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