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FDA 510(k)

Internal Locking Plate and Screw Fixation System

K-Number: K232394 · 2023-12-15

ApplicantChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Decision Date2023-12-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Internal Locking Plate and Screw Fixation System is a medical device manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under approval number K232394. 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 Internal Locking Plate and Screw Fixation System?

Internal Locking Plate and Screw Fixation System is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K232394.

When was Internal Locking Plate and Screw Fixation System approved by the FDA?

Internal Locking Plate and Screw Fixation System received FDA 510(k) clearance on 2023-12-15, under approval number K232394.

What company makes Internal Locking Plate and Screw Fixation System?

Internal Locking Plate and Screw Fixation System is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd..

What is the FDA product code for Internal Locking Plate and Screw Fixation System?

The FDA product code for Internal Locking Plate and Screw Fixation System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K222031Spinal Inner Fixation System K230456SGM Femoral Nail System K223776PEEK Spinal Infusion Cage

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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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