Indy 1020-38270815

• FDA 510(k) K182406 decided 22 Feb 2019 Active
• FDA GUDID UDI-DI 00843210143163 listed 22 Jul 2024 Listed

1. 22 Feb 2019 Cleared FDA 510(k) K182406
2. 22 Jul 2024 Listed FDA GUDID 00843210143163

Trade name

Indy

Generic name

Spinal implant trial

Model / reference

1020-38270815

Primary DI / UDI-DI

00843210143163

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

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• TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System by Life Spine, Inc.
• STRYKER SPINE AVS PL PEEK SPACERS by Stryker Corp.
• PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE by Innovative Spinal Technologies, Inc.
• NuVasive CoRoent Ti-C System by Nu Vasive, Incorporated
• Cascadia Interbody System by K2M, INC.

• 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

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  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 →