VERTACONNECT TLIF Cage

510(k) Number

K203327 ↗

FDA product code

MAX

Device class

Class II

Regulation

21 CFR Part 888.3080

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

• Atlas Spine Expandable Interbody System by ATLAS SPINE INC.
• ROCCIA® MultiLIF by Silony Medical GmbH
• Genesys Spine 3DP Lumbar Interbody System by Genesys Spine
• PEEK-OPTIMA ALIF SPACER by BIOMET SPINE LLC
• Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage by Stryker Spine
• ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251205 by MEDTRONIC SOFAMOR DANEK, INC.
• Conduit Lateral Lumbar Intervertebral Fusion Cage, Conduit Instruments by MEDOS INTERNATIONAL SARL
• DePuy CONDUIT LLIF Angled Inserters by ENZTEC LIMITED
• CAPSTONE SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
• ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER by Icotec

• DIPLOMAT Guide wire, trocar/round

  Class I

  FDA 510(k) K151704 Active Cleared 13 Apr 2016 GUDID on market

• DIPLOMAT Guide wire, round/round

  Class I

  FDA 510(k) K151704 Active Cleared 13 Apr 2016 GUDID on market

• POSEIDON ST Palm handle, torque limiter

  Class I

  GUDID on market

• POSEIDON ST Main body, extension

  Class II

  GUDID on market

See all devices from SIGNUS Medizintechnik GmbH →