Sochi A16-18-0110

• FDA 510(k) K210887 decided 20 Aug 2021 Active
• FDA GUDID UDI-DI 00843210173924 listed 2 Jan 2024 Listed

1. 20 Aug 2021 Cleared FDA 510(k) K210887
2. 2 Jan 2024 Listed FDA GUDID 00843210173924

Trade name

Sochi

Generic name

Bone-screw internal spinal fixation system rod

Model / reference

A16-18-0110

Primary DI / UDI-DI

00843210173924

510(k) Number

K210887 ↗

FDA product code

KWP, NKG

GMDN term

Bone-screw internal spinal fixation system rod

Device class

Class II

Regulation number

888.3050, 888.3075

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Bone-screw internal spinal fixation system rod

Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).

• CD HORIZON® Spinal System 1555000500 by MEDTRONIC SOFAMOR DANEK, INC.
• ISSYS LP SPINAL FIXATION SYSTEM by Custom Spine, Inc.
• RENOIR POSTERIOR CERVIAL FIXATION SYSTEM by Accel Spine
• BLACKBIRD SPINAL SYSTEM by Choicespine, LP
• TSRH SACRAL L-CONNECTOR by Danek Medical, Inc.
• PERLA ® TL TLF-5S C2 80-S by Spineart
• CASPIAN SPINAL SYSTEM by K2M, INC.
• RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM by Reliance Medical Systems, LLC
• CD HORIZON® Spinal System 55840015550 by MEDTRONIC SOFAMOR DANEK, INC.
• SOLSTICE OCT System by Life Spine, 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

  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 →