Secure-C 414.108S

• FDA PMA P100003 decided 28 Sep 2012 Active
• FDA GUDID UDI-DI 00889095154801 listed 29 Sep 2015 Listed

1. 28 Sep 2012 Approved FDA PMA P100003
2. 29 Sep 2015 Listed FDA GUDID 00889095154801

Trade name

Secure-C

Generic name

Cervical total intervertebral disc prosthesis, modular

Model / reference

414.108S

Primary DI / UDI-DI

00889095154801

PMA number

P100003 ↗

FDA product code

MJO

GMDN term

Cervical total intervertebral disc prosthesis, modular

Device class

Class III

GUDID distribution status

In Commercial Distribution

Size

Depth — 11 Millimeter

Width — 12 Millimeter

Height — 8 Millimeter

Category: Cervical total intervertebral disc prosthesis, modular

Other devices filed under FDA product code MJO (PROSTHESIS, INTERVERTEBRAL DISC).

• Prestige LP Cervical Disc System by MEDTRONIC SOFAMOR DANEK, INC.
• Mobi-C Cervical Disc Prosthesis (One-Level Indication) by Highridge Medical, LLC.
• ProDisc-L Total Disc Replacement by Centinel Spine, LLC
• ProDisc-C Total Disc Replacement by Centinel Spine, LLC
• PCM Cervical Disc System by Nuvasive, Inc.
• ACTIVL Artificial Disc by Highridge Medical, LLC.
• Prestige Cervical Disc by MEDTRONIC SOFAMOR DANEK, INC.
• Bryan Cervical Disc Prosthesis by Companion Spine France SAS
• BAGUERA®C Cervical Disc Prosthesis by Spineart USA, Inc.
• Charite Artificial Disc by Depuy Spine, 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. →