Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Proficient® Posterior Cervical Spine System

K-Number: K172594 · 2017-12-15

ApplicantSpine Wave, Inc.
Decision Date2017-12-15
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 2017-12-15 under approval number K172594. 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 2017-12-15. It is manufactured by Spine Wave, Inc.. The 510(k) number is K172594.

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

Proficient® Posterior Cervical Spine System received FDA 510(k) clearance on 2017-12-15, under approval number K172594.

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

Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K173175Paramount Anterior Cervical Cage System K172175CapSure® PS 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.

↑