Sochi A16-18-1105

• FDA 510(k) K210887 decided 20 Aug 2021 Active
• FDA GUDID UDI-DI 00843210173719 listed 3 Jan 2024 Listed

1. 20 Aug 2021 Cleared FDA 510(k) K210887
2. 3 Jan 2024 Listed FDA GUDID 00843210173719

Trade name

Sochi

Generic name

Bone-screw internal spinal fixation system rod

Model / reference

A16-18-1105

Primary DI / UDI-DI

00843210173719

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).

• ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR by Acromed Corp.
• CD HORIZON® Spinal System 55410005550 by MEDTRONIC SOFAMOR DANEK, INC.
• VERTEX RECONSTRUCTION SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
• TRANSVERSE TRACTION ASSEMBLY by Zimmer, Inc.
• ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM by Alphatec/Nexmed
• RELIANCE SPINAL SCREW SYSTEM by Reliance Medical Systems, LLC
• PERLA ® CPF-SR C0 65-S by Spineart
• MOUNTAINEER 188318318 by MEDOS INTERNATIONAL SARL
• PERLA ® CPF-SR C0 80-S by Spineart
• MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM by Theken Spine, LLC

• 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 →