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FDA 510(k)

VERTACONNECT TLIF Cage

K-Number: K203327 · 2021-01-25

ApplicantSignus Medizintechnik
Decision Date2021-01-25
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTACONNECT TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K203327. 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 VERTACONNECT TLIF Cage?

VERTACONNECT TLIF Cage is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Signus Medizintechnik. The 510(k) number is K203327.

When did VERTACONNECT TLIF Cage receive FDA 510(k) clearance?

VERTACONNECT TLIF Cage received FDA 510(k) clearance on 2021-01-25, under 510(k) number K203327.

Who is the listed applicant for VERTACONNECT TLIF Cage?

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

What is the FDA product code for VERTACONNECT TLIF Cage?

The FDA product code for VERTACONNECT TLIF Cage is MAX.

Other records listing Signus Medizintechnik 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.

K243188CYLOX® STK241438Signus Tetris™ St; Signus Tetris™ R StK220658COSY Cervicothoracic Occipital Rod-Screw SystemK212755SIGNUS SACRONAIL® Transsacral Stabilization SystemK151704Diplomat® Spinal System

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.

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