Brickyard ALIF FA32240816

• FDA 510(k) K182406 decided 22 Feb 2019 Active
• FDA GUDID UDI-DI 00843210140001 listed 29 Aug 2024 Listed

1. 22 Feb 2019 Cleared FDA 510(k) K182406
2. 29 Aug 2024 Listed FDA GUDID 00843210140001

Trade name

Brickyard ALIF

Generic name

Spinal implant trial

Model / reference

FA32240816

Description

32mm x 24mm, 8°, 16mm PEEK Spacer

Primary DI / UDI-DI

00843210140001

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).

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• 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
• Expandable Titanium PLIF/TLIF System by Spectrum Spine, LLC
• icotec Lumbar Cage ETurn TLIF 15 x 16 mm 12-58-16-32-15-ITi by icotec AG
• Kuros TLIF Cage by Kuros Biosciences B.V
• PLIF LITE AND TLIF LITE by Sintea Plustek, LLC
• JULIET ® Ti LL JLT-S0 40 10-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 →