SUPSTANCE Large - The SUPSTANCE Large VBR system is a PEEK Optima - H.P.I.

Duns Number:268469389

Device Description: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system in 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.

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More Product Details

Catalog Number

100125300

Brand Name

SUPSTANCE Large

Version/Model Number

100125300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Device Record Status

Public Device Record Key

5da9b1b7-f457-40dc-9ad6-0866e0ee9b6f

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

November 12, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"H.P.I." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 98