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FDA 510(k)

MOSS 100 Pedicle Screw System

K-Number: K162232 · 2016-11-17

ApplicantBiedermann Motech GmbH & Co. KG
Decision Date2016-11-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOSS 100 Pedicle Screw System is a medical device manufactured by Biedermann Motech GmbH & Co. KG. It received FDA 510(k) clearance on 2016-11-17 under approval number K162232. 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 MOSS 100 Pedicle Screw System?

MOSS 100 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Biedermann Motech GmbH & Co. KG. The 510(k) number is K162232.

When was MOSS 100 Pedicle Screw System approved by the FDA?

MOSS 100 Pedicle Screw System received FDA 510(k) clearance on 2016-11-17, under approval number K162232.

What company makes MOSS 100 Pedicle Screw System?

MOSS 100 Pedicle Screw System is manufactured by Biedermann Motech GmbH & Co. KG.

What is the FDA product code for MOSS 100 Pedicle Screw System?

The FDA product code for MOSS 100 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 Biedermann Motech GmbH & Co. KG

K170890TELIX K Interbody System K181821MOSS VRS Spinal System K203607MOSS VRS Spinal System

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 K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162576FORTEZZA Spinal Stabilization SystemOsso Surgical

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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