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FDA 510(k)

Paramount Anterior Cervical Cage System

K-Number: K173175 · 2017-11-01

ApplicantSpine Wave, Inc.
Decision Date2017-11-01
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paramount Anterior Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K173175. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paramount Anterior Cervical Cage System?

Paramount Anterior Cervical Cage System is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Spine Wave, Inc.. The 510(k) number is K173175.

When did Paramount Anterior Cervical Cage System receive FDA 510(k) clearance?

Paramount Anterior Cervical Cage System received FDA 510(k) clearance on 2017-11-01, under 510(k) number K173175.

Who is the listed applicant for Paramount Anterior Cervical Cage System?

The FDA 510(k) record lists Spine Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paramount Anterior Cervical Cage System?

The FDA product code for Paramount Anterior Cervical Cage System is OVE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Other records listing Spine Wave, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemK261159Exceed® Biplanar Expandable Interbody SystemK243816Testa TP Pivoting Spacer SystemK251131Annex® 2 Adjacent Level SystemK243514Salvo® Robotic Navigation InstrumentsK240685Salvo® Spine System

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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