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FDA 510(k)

Proficient® Posterior Cervical Spine System

K-Number: K181440 · 2018-07-30

ApplicantSpine Wave, Inc.
Decision Date2018-07-30
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Proficient® Posterior Cervical Spine System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2018-07-30 under approval number K181440. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Proficient® Posterior Cervical Spine System?

Proficient® Posterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2018-07-30. It is manufactured by Spine Wave, Inc.. The 510(k) number is K181440.

When was Proficient® Posterior Cervical Spine System approved by the FDA?

Proficient® Posterior Cervical Spine System received FDA 510(k) clearance on 2018-07-30, under approval number K181440.

What company makes Proficient® Posterior Cervical Spine System?

Proficient® Posterior Cervical Spine System is manufactured by Spine Wave, Inc..

What is the FDA product code for Proficient® Posterior Cervical Spine System?

The FDA product code for Proficient® Posterior Cervical Spine System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System

View all 22 devices →

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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