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FDA 510(k)

BPS Wrist Fracture System

K-Number: K250498 · 2025-03-17

ApplicantOrthonovis, Inc.
Decision Date2025-03-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BPS Wrist Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K250498. 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 Wrist Fracture System?

BPS Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Orthonovis, Inc.. The 510(k) number is K250498.

When did BPS Wrist Fracture System receive FDA 510(k) clearance?

BPS Wrist Fracture System received FDA 510(k) clearance on 2025-03-17, under 510(k) number K250498.

Who is the listed applicant for BPS Wrist Fracture System?

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 Wrist Fracture System?

The FDA product code for BPS Wrist Fracture System is HRS.

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) SystemK250055BPS - Bone Fragment Fixation Plates, Screws and WashersK242343BPS 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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