Stryker/K2M CAPRI. Expandable Corpectomy Device. EXTERNAL HOUSING. Catalog #210127430L0

Vendor/Manufacturer: Stryker/K2M

Product/Product Line: CAPRI External Housing

Vendor/Manufacturer Catalog #: 210127430L0

Global Unique Device (GUD) Primary Device Identifier Number:

10888857033191

Global Unique Device (GUD) Device Description:

External Housing

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Vertebral body prosthesis, non-sterile

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: MQP

FDA Classification Product Code Device Name:

Spinal Vertebral Body Replacement Device

Category 1: Spine

Category 2: Expandable Corpectomy Devices

Category 3: External Housing

FDA Premarket Submissions: K142016

SUBSTANTIALLY EQUIVALENT to the following products:

1. DePuy Surgical Titanium Mesh

2. DePuy X-Mesh

3. Ulrich Obelisc

4. K2M SANTORINI Corpectomy Cage System