Xia® 3 System - Serrato® · 482618540V
VB Spine LLC · 482618540V
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Device description
- 482618540V
- Public device record key
- b147053c-3ac8-47fb-b8b3-035f2f750b6e
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 119508156
- Is labeled as no nrl
- false
- Is single use
- false
- Is otc
- false
- Version or model number
- 482618540V
- Has manufacturing date
- false
- Brand name
- Xia® 3 System - Serrato®
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- 482618540V
- Company name
- VB Spine LLC
- Public version status
- New
- Has expiration date
- false
- Is hct p
- false
- Publish date
- 2026-07-24
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- false
- Identifiers
- ID
- 10888857598850
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- KWP
- Name
- APPLIANCE, FIXATION, SPINAL INTERLAMINAL
- Harmonized identifiers (openFDA)
- Device name
- Appliance, Fixation, Spinal Interlaminal
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3050
- Device class
- 2
- Code
- NKB
- Name
- Thoracolumbosacral pedicle screw system
- Harmonized identifiers (openFDA)
- Device name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3070
- Device class
- 2
- Code
- KWQ
- Name
- Appliance, fixation, spinal intervertebral body
- Harmonized identifiers (openFDA)
- Device name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3060
- Device class
- 2
- Customer contacts
- Phone
- +1(571)919-2000
- alex.lopez@vbspineco.com
- Gmdn terms
- Code
- 46651
- Name
- Spinal bone screw, non-bioabsorbable
- Implantable
- true
- Code status
- Active
- Definition
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
- Device sizes
- Type
- Outer Diameter
- Value
- 8.5
- Unit
- Millimeter
- Type
- Length
- Value
- 40
- Unit
- Millimeter