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FDA 510(k)

primaLOK™ SP Interspinous Fusion System

K-Number: K231807 · 2023-08-15

ApplicantWenzel Spine, Inc.
Decision Date2023-08-15
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

primaLOK™ SP Interspinous Fusion System is a medical device manufactured by Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2023-08-15 under approval number K231807. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the primaLOK™ SP Interspinous Fusion System?

primaLOK™ SP Interspinous Fusion System is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Wenzel Spine, Inc.. The 510(k) number is K231807.

When was primaLOK™ SP Interspinous Fusion System approved by the FDA?

primaLOK™ SP Interspinous Fusion System received FDA 510(k) clearance on 2023-08-15, under approval number K231807.

What company makes primaLOK™ SP Interspinous Fusion System?

primaLOK™ SP Interspinous Fusion System is manufactured by Wenzel Spine, Inc..

What is the FDA product code for primaLOK™ SP Interspinous Fusion System?

The FDA product code for primaLOK™ SP Interspinous Fusion System is PEK.

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 NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by Wenzel Spine, Inc.

K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System K231076VariLift®-C Interbody Fusion System K250247panaSIa SI Fusion System

Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.

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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