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

FDA 510(k)

Neurostructures Cavetto® [MAX] Cervical Cage System

K-Number: K181590 · 2018-11-08

ApplicantNeurostructures, Inc.
Decision Date2018-11-08
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Neurostructures Cavetto® [MAX] Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K181590. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurostructures Cavetto® [MAX] Cervical Cage System?

Neurostructures Cavetto® [MAX] Cervical Cage System is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Neurostructures, Inc.. The 510(k) number is K181590.

When did Neurostructures Cavetto® [MAX] Cervical Cage System receive FDA 510(k) clearance?

Neurostructures Cavetto® [MAX] Cervical Cage System received FDA 510(k) clearance on 2018-11-08, under 510(k) number K181590.

Who is the listed applicant for Neurostructures Cavetto® [MAX] Cervical Cage System?

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

What is the FDA product code for Neurostructures Cavetto® [MAX] Cervical Cage System?

The FDA product code for Neurostructures Cavetto® [MAX] Cervical Cage System is ODP.

Other records listing Neurostructures, 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.

K202190Oculus-SA Lumbar Cage SystemK200115Cavetto-SA Cervical Cage SystemK201769Cavetto [MAX] Cervical Cage SystemK200927Transept Cervical Plate SystemK192248Cortina™ [MAX] Lumbar Cage SystemK182195Arco™-SA Lumbar Cage System

View all 14 devices →

Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.

↑