Mesh 1007653

• FDA 510(k) K023319 decided 4 Mar 2003 Active
• FDA GUDID UDI-DI 00887517055408 listed 24 Oct 2015 Listed

1. 4 Mar 2003 Cleared FDA 510(k) K023319
2. 24 Oct 2015 Listed FDA GUDID 00887517055408

Trade name

Mesh

Generic name

Vertebral body prosthesis

Model / reference

1007653

Primary DI / UDI-DI

00887517055408

510(k) Number

K023319 ↗

FDA product code

MQP

GMDN term

Vertebral body prosthesis

Device class

Class II

Regulation number

888.3060

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Vertebral body prosthesis

Other devices filed under FDA product code MQP (SPINAL VERTEBRAL BODY REPLACEMENT DEVICE).

• CONCORDE 187823110 by MEDOS INTERNATIONAL SARL
• VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX by Stryker Spine
• TITANIUM MESH IMPLANT by Interpore Cross Intl.
• T2 STRATOSPHERE™ Expandable Corpectomy System by MEDTRONIC SOFAMOR DANEK, INC.
• BENGAL 177304211 by Depuy Spine, Inc.
• STACKABLE CAGE SYSTEM by Depuy Motech Acromed
• 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.

• CoRoent 6791713P2

  Class II

  FDA 510(k) K140319 Active Cleared 9 Oct 2014 GUDID on market

• CoRoent 6791712P2

  Class II

  FDA 510(k) K140319 Active Cleared 9 Oct 2014 GUDID on market

• ReLine 3800035

  Class II

  FDA 510(k) K191553 Active Cleared 14 Aug 2019 GUDID on market

• ReLine 3800240

  Class II

  FDA 510(k) K191553 Active Cleared 14 Aug 2019 GUDID on market

See all devices from NuVasive, LLC →