Mesh 1007633

• FDA 510(k) K023319 decided 4 Mar 2003 Active
• FDA GUDID UDI-DI 00887517054913 listed 24 Oct 2015 Listed

1. 4 Mar 2003 Cleared FDA 510(k) K023319
2. 24 Oct 2015 Listed FDA GUDID 00887517054913

Trade name

Mesh

Generic name

Vertebral body prosthesis

Model / reference

1007633

Primary DI / UDI-DI

00887517054913

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).

• KONG-TL VBR System, Extension Rod 44-075 by icotec AG
• SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX by Sintea Biotech, Inc.
• DSC/ALF SPINAL SYSTEM by Sintea Plastek, LLC
• Trabecular Metal Vertebral Body Replacement (VBR), Model #06-115, 06-155 by Zimmer Trabecular Metal Technology, Inc.
• PEEK Tetris Spinal Implant by Signus Medical
• BENGAL 177300209 by Depuy Spine, Inc.
• ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) by Arftx Medical, LLC
• Hedrocel Vertebral Body Replacement, Models 06-112-00XX2 and 06-132-10XX2 by Implex Corp.
• KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm 44-074 by icotec AG
• Depuy Acromed Vbr System by Depuyacromed

• 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 →