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FDA 510(k)

The OsteoCentric Bone Plate and Screw System

K-Number: K250494 · 2025-03-18

ApplicantOsteoCentric Technologies
Decision Date2025-03-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The OsteoCentric Bone Plate and Screw System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2025-03-18 under approval number K250494. 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 The OsteoCentric Bone Plate and Screw System?

The OsteoCentric Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by OsteoCentric Technologies. The 510(k) number is K250494.

When was The OsteoCentric Bone Plate and Screw System approved by the FDA?

The OsteoCentric Bone Plate and Screw System received FDA 510(k) clearance on 2025-03-18, under approval number K250494.

What company makes The OsteoCentric Bone Plate and Screw System?

The OsteoCentric Bone Plate and Screw System is manufactured by OsteoCentric Technologies.

What is the FDA product code for The OsteoCentric Bone Plate and Screw System?

The FDA product code for The OsteoCentric Bone Plate and Screw System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Other Devices by OsteoCentric Technologies

K211290Cannulated Fasteners and Nuts K210754Cannulated Fasteners and Nuts K222512Integrity-SI Fusion System K221332OsteoCentric Spine MIS Pedicle Fastener System K230242OsteoCentric Dental Implant System K230226Integrity-SI® Fusion System

View all 11 devices →

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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