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)

XCage™ Interbody Fusion System

K-Number: K160076 · 2016-10-13

ApplicantOuroboros Medical, Inc.
Decision Date2016-10-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XCage™ Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Ouroboros Medical, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K160076. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XCage™ Interbody Fusion System?

XCage™ Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Ouroboros Medical, Inc.. The 510(k) number is K160076.

When did XCage™ Interbody Fusion System receive FDA 510(k) clearance?

XCage™ Interbody Fusion System received FDA 510(k) clearance on 2016-10-13, under 510(k) number K160076.

Who is the listed applicant for XCage™ Interbody Fusion System?

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

What is the FDA product code for XCage™ Interbody Fusion System?

The FDA product code for XCage™ Interbody Fusion System is MAX.

Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.

↑