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)

Double Medical Cage System

K-Number: K172828 · 2018-02-01

ApplicantDouble Medical Technology, Inc.
Decision Date2018-02-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Double Medical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-02-01 under 510(k) number K172828. 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 Double Medical Cage System?

Double Medical Cage System is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K172828.

When did Double Medical Cage System receive FDA 510(k) clearance?

Double Medical Cage System received FDA 510(k) clearance on 2018-02-01, under 510(k) number K172828.

Who is the listed applicant for Double Medical Cage System?

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

What is the FDA product code for Double Medical Cage System?

The FDA product code for Double Medical Cage System is MAX.

Other records listing Double Medical Technology, 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.

K252729Universal Spinal SystemK242348Locking Screw,CoCrMoK233078Posterior Cervical Spine SystemK223753Cervical Plate SystemK221150Advanced Bone PlateK221088Anatomic Bone Plate

View all 12 devices →

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.

↑