Fortify 151.704S

• FDA 510(k) K162315 decided 9 Nov 2017 Active
• FDA GUDID UDI-DI 00889095618990 listed 15 Sep 2022 Listed

1. 9 Nov 2017 Cleared FDA 510(k) K162315
2. 15 Sep 2022 Listed FDA GUDID 00889095618990

Trade name

Fortify

Generic name

Vertebral body prosthesis

Model / reference

151.704S

Primary DI / UDI-DI

00889095618990

510(k) Number

K162315 ↗

FDA product code

MQP, PLR

GMDN term

Vertebral body prosthesis

Device class

Class II

Regulation number

888.3060

GUDID distribution status

In Commercial Distribution

Category: Vertebral body prosthesis

Other devices filed under FDA product code MQP (Spinal vertebral body replacement device).

• ATLAS SPINE VERTEBRAL BODY REPLACEMENT by ATLAS SPINE INC.
• STAXX XD SYSTEM by Spine Wave, Inc.
• MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 by Interpore Cross Intl.
• MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM by Quantum Orthopedics, Inc.
• CONCORDE 187823212 by MEDOS INTERNATIONAL SARL
• BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS by Blackstone Medical, Inc.
• HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 by Implex Corp.
• VU E*POD VERTEBRAL BODY REPLACEMENT by Theken Spine, LLC
• SYNTHES SYNMESH SPACER SYSTEM by Synthes (Usa)
• PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE by Pioneer Surgical Technology Inc.

• Cervical Artificial Discs

  Class III

  CE/MDR ×2 Active Valid to May 2029

• Anthem 2171.6509

  Class II

  FDA 510(k) K163361 Active Cleared 7 Apr 2017 GUDID on market

• Anthem 2171.6513

  Class II

  FDA 510(k) K163361 Active Cleared 7 Apr 2017 GUDID on market

• Anthem 2171.6511

  Class II

  FDA 510(k) K163361 Active Cleared 7 Apr 2017 GUDID on market

See all devices from Globus Medical, Inc. →