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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 a medical device manufactured by Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-02-06 under approval 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. It is manufactured by Orthonovis, Inc.. The 510(k) number is K250055.

When was BPS - Bone Fragment Fixation Plates, Screws and Washers approved by the FDA?

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

What company makes BPS - Bone Fragment Fixation Plates, Screws and Washers?

BPS - Bone Fragment Fixation Plates, Screws and Washers is manufactured by Orthonovis, Inc..

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

NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING NCT07520227 Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle COMPLETED NCT07153120 Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures COMPLETED

Other Devices by Orthonovis, Inc.

K213905ONX Large External Fixation System K242343BPS Wrist Fracture System K252758Cannulated Screw and Kirschner (K wire) System K250498BPS Wrist Fracture System

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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