Spinal Vertebral Body Replacement Device – Cervical

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Shandong. All of them are contract manufacturers, able to build to a buyer’s own specification.

Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer

What Is It?

Vertebral body replacement in the cervical spine.

How Is PLR Classified?

Spinal Vertebral Body Replacement Device – Cervical is FDA product code PLR, Class 2, 21 CFR 888.3060.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

Spinal Vertebral Body Replacement Device - Cervical

Palo Alto ™

Cvbr LCM 23.25 MM

Spinal Vertebral Body Replacement Device - Cervical

Zavation Screw Caddy

Zavation Normandy Lumbar SET Screw Caddy

Spinal Vertebral Body Replacement Device - Cervical

Kong-TL VBR System, Locking Rod

Catalogue number 44-040-02, listed by Icotec AG, Switzerland, under Spinal Vertebral Body Replacement Device - Cervical. 1 manufacturer in China is registered for this product code.

Spinal Vertebral Body Replacement Device - Cervical

Zavation Caddy

Normandy Cervical Caddy - 16x14mm Implants

Spinal Vertebral Body Replacement Device - Cervical

Zavation Custom

Custom Torque Shaft – T8

Spinal Vertebral Body Replacement Device - Cervical

Zavation Implant Tray

Zavation Normandy Lumbar Implant Tray 2

Spinal Vertebral Body Replacement Device - Cervical

Zavation Endplate Caddy

Zavation Normandy Lumbar Implant Round AND Oval Endplate Caddy

Spinal Vertebral Body Replacement Device - Cervical

Zavation Standard Base

Zavation Normandy Lumbar Standard Base

Spinal Vertebral Body Replacement Device - Cervical

Zavation Tray

Zavation Normandy Lumbar Rectangular Tray

Spinal Vertebral Body Replacement Device - Cervical

Zavation Sizer Caddy

Zavation Normandy Lumbar Implant Round AND Oval Sizer Caddy

Spinal Vertebral Body Replacement Device - Cervical

CarboClear Cervical Cage / VBR System

Insertion Handle for use with the CarboClear Cervical Cage / VBR

Spinal Vertebral Body Replacement Device - Cervical

T2 Stratosphere™ Expandable Corpectomy System

Endcap 4361135 13MM 15 Degree Sterile

Spinal Vertebral Body Replacement Device - Cervical

Santorini™ Corpectomy Cage System

Threaded Clip Inserter, Size 12x17 mm

Spinal Vertebral Body Replacement Device - Cervical

Zavation Base

Zavation Normandy Lumbar Rectangular Base

Spinal Vertebral Body Replacement Device - Cervical

Kong-TL VBR System, Expansion Handle

Catalogue number 44-040-01, listed by Icotec AG, Switzerland, under Spinal Vertebral Body Replacement Device - Cervical. 1 manufacturer in China is registered for this product code.

Spinal Vertebral Body Replacement Device - Cervical

Zavation Implant Caddy

Zavation Normandy Lumbar Implant Body Caddy

Spinal Vertebral Body Replacement Device - Cervical

Fortify

FORTIFY 12mm Upper Endplate, 12x14mm Footprint, 0°, No Spikes

Spinal Vertebral Body Replacement Device - Cervical

CarboClear Cervical VBR System

A cervical spine vertebral body replacement device

Spinal Vertebral Body Replacement Device - Cervical

Zavation Instrument Tray

Zavation Normandy Lumbar Instrument Tray 1

Spinal Vertebral Body Replacement Device - Cervical

Zavation

Small Corpectomy Cage Inserter Knob Assembly

Spinal Vertebral Body Replacement Device - Cervical

MediExpand Cervical Expandable VBR System

MediExpand-cervical expandable 43-51mm light blue

Spinal Vertebral Body Replacement Device - Cervical

X-Core

X-CORE Mini Inserter, Ø12mm Dismantlable

Spinal Vertebral Body Replacement Device - Cervical

C-VBR

Corpectomy Cage, Lordotic, Size 10x12x19.75 mm

Spinal Vertebral Body Replacement Device - Cervical

Verteloc Spinal System

17 catalogue numbers from 131-14-1005, listed by Signature Orthopaedics PTY Limited, Australia, under Spinal Vertebral Body Replacement Device - Cervical. 1 manufacturer in China is registered for this product code.

Spinal Vertebral Body Replacement Device - Cervical

Trabis®

domed cage

Spinal Vertebral Body Replacement Device - Cervical

Palo Alto Corpectomy Cage System

Corpectomy Cage, Lordotic, Size 10x12x26.75 mm, 11 Deg.

Spinal Vertebral Body Replacement Device - Cervical

Capri™ Corpectomy Cage System

Corpectomy Cage with Set Screw, Size 13x16mm, 38-54mm, 10°, 0-20°

Spinal Vertebral Body Replacement Device - Cervical

Ascend

12mm Core Endplate Trial, Trp 14x12/16x14mm

Spinal Vertebral Body Replacement Device - Cervical

Matrixx System

The NEXXT MATRIXX System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The filing describes the implants as structural…

Spinal Vertebral Body Replacement Device - Cervical

Zavation Inserter

Custom Corpectomy Cage Inserter

Spinal Vertebral Body Replacement Device - Cervical

Colosseum

COLOSSEUM Mesh, 14x16mm, 24mm, curved

Spinal Vertebral Body Replacement Device - Cervical

Alta

Corpectomy Caliper

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer