Brickyard 1030-32241214

• FDA 510(k) K182406 decided 22 Feb 2019 Active
• FDA GUDID UDI-DI 00843210185378 listed 29 Aug 2024 Listed

1. 22 Feb 2019 Cleared FDA 510(k) K182406
2. 29 Aug 2024 Listed FDA GUDID 00843210185378

Trade name

Brickyard

Generic name

Spinal implant trial

Model / reference

1030-32241214

Primary DI / UDI-DI

00843210185378

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).

• ATEC Lateral Interbody System by ALPHATEC SPINE, INC.
• NuVasive® Lumbar Interbody Implants by Nu Vasive, Incorporated
• Expandable Lumbar Fusion Cage (Type I, Type II) by Shanghai Reach Medical Instrument Co., Ltd
• Ali Interbody Fusion System by Raed M. Ali, M.D., Inc.
• Leva(TM) Spacer System by Spine Wave, Inc.
• CAPSTONE® Spinal System 2991426 by MEDTRONIC SOFAMOR DANEK, INC.
• Medtronic 9735522 by Medtronic Navigation Inc.
• INTERFORM INTERBODY CAGE SYSTEM by Next Orthosurgical
• Spinal Instrument 99762000 by Clariance, Inc.
• icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm 12-59-82509 by icotec AG

• 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 →