Brickyard 1020-32242018

• FDA 510(k) K182406 decided 22 Feb 2019 Active
• FDA GUDID UDI-DI 00843210178363 listed 29 Aug 2024 Listed

1. 22 Feb 2019 Cleared FDA 510(k) K182406
2. 29 Aug 2024 Listed FDA GUDID 00843210178363

Trade name

Brickyard

Generic name

Spinal implant trial

Model / reference

1020-32242018

Primary DI / UDI-DI

00843210178363

510(k) Number

K182406 ↗

FDA product code

MAX

GMDN term

Spinal implant trial

Device class

Class II

Regulation number

888.3080

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Spinal implant trial

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

• Perimeter Interbody Fusion Device by MEDTRONIC SOFAMOR DANEK, INC.
• MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF by MIRUS LLC
• Lucent Ti-Bond Systems by SPINAL ELEMENTS, INC.
• nva, nvp, and nvt by NVISION BIOMEDICAL TECHNOLOGIES, INC
• SCARLET® AL-T Intervertebral body fusion device SCA-LL 30 20-S by Spineart
• CONCORDE 187827212 by MEDOS INTERNATIONAL SARL
• Lumbar IBF System by SPINEFRONTIER, INC.
• ProLift Wedge Expandable Spacer System by Life Spine, Inc.
• Twin Peaks Lumbar Interbody Fusion System by Spineway SA
• JULIET ® Ti LL JLT-MY 55 14-S by Spineart

• Sochi 300-0704

  Class I

  FDA 510(k) K210887 Active Cleared 20 Aug 2021 GUDID on market

• Monaco Pedicle Screw System 880-1044

  Class I

  FDA 510(k) K181339 Active Cleared 24 Jul 2018 GUDID on market

• Brickyard Stand-Alone ALIF 1030-4008

  Class I

  FDA 510(k) K211837 Active Cleared 19 Apr 2022 GUDID on market

• Indy 1020-38271213

  Class II

  FDA 510(k) K182406 Active Cleared 22 Feb 2019 GUDID on market

See all devices from Altus Spine →