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FDA 510(k)

Intai Anatomic Locking Plate and Screw System

K-Number: K201229 · 2022-03-11

ApplicantIntai Technology Corporation
Decision Date2022-03-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intai Anatomic Locking Plate and Screw System is a medical device manufactured by Intai Technology Corporation. It received FDA 510(k) clearance on 2022-03-11 under approval number K201229. 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 Intai Anatomic Locking Plate and Screw System?

Intai Anatomic Locking Plate and Screw System is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Intai Technology Corporation. The 510(k) number is K201229.

When was Intai Anatomic Locking Plate and Screw System approved by the FDA?

Intai Anatomic Locking Plate and Screw System received FDA 510(k) clearance on 2022-03-11, under approval number K201229.

What company makes Intai Anatomic Locking Plate and Screw System?

Intai Anatomic Locking Plate and Screw System is manufactured by Intai Technology Corporation.

What is the FDA product code for Intai Anatomic Locking Plate and Screw System?

The FDA product code for Intai Anatomic Locking 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 NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING 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

Other Devices by Intai Technology Corporation

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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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