SUPSTANCE Large 100122325

GUDID 03700449614536

The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma (i.e, fracture) management procédures.

H.P.I.

Polymeric spinal interbody fusion cage

• Primary Device ID: 03700449614536
• NIH Device Record Key: cc5a34bf-25b8-415c-8bbd-d1d083635d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPSTANCE Large
• Version Model Number: 100122325
• Catalog Number: 100122325
• Company DUNS: 268469389
• Company Name: H.P.I.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700449614536 [Primary]

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03700449614536]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-11-12

On-Brand Devices [SUPSTANCE Large]

• 03700449614826: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614819: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614802: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614796: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614789: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614772: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614765: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614758: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614741: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614710: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614703: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614697: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614680: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614673: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614666: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614659: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614642: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614635: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614628: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614611: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614604: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614598: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614581: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614574: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614567: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614550: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614543: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614536: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614529: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614512: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614505: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614499: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614482: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614475: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614468: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614451: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614444: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614437: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614420: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614413: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614406: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614390: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614383: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614376: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614369: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614352: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
• 03700449614345: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended