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FDA 510(k)

Reform Pedicle Screw System

K-Number: K242297 · 2024-12-17

ApplicantPrecision Spine, Inc.
Decision Date2024-12-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reform Pedicle Screw System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K242297. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reform Pedicle Screw System?

Reform Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Precision Spine, Inc.. The 510(k) number is K242297.

When was Reform Pedicle Screw System approved by the FDA?

Reform Pedicle Screw System received FDA 510(k) clearance on 2024-12-17, under approval number K242297.

What company makes Reform Pedicle Screw System?

Reform Pedicle Screw System is manufactured by Precision Spine, Inc..

What is the FDA product code for Reform Pedicle Screw System?

The FDA product code for Reform Pedicle Screw System is NKB.

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

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System

View all 17 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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