SUPSTANCE Small 100116036

GUDID 03700449614161

The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the cervical and in the thoracolumbar spine (C3 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma management and to replace a partially removed vertebral body in the management of degenerative disorders.

H.P.I.

Polymeric spinal interbody fusion cage
Primary Device ID03700449614161
NIH Device Record Key5e8aabaf-9ca8-4d46-b906-ce0ed554e166
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUPSTANCE Small
Version Model Number100116036
Catalog Number100116036
Company DUNS268469389
Company NameH.P.I.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Width16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103700449614161 [Primary]

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700449614161]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2015-11-12

On-Brand Devices [SUPSTANCE Small]

00370049613881The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614307The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614284The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614260The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614246The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614222The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614208The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614185The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614161The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614147The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614123The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614109The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614086The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614062The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614048The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614024The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449614000The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613980The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613966The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613942The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613928The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613904The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613867The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613843The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613829The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613805The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613782The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613768The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613744The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613720The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613706The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613683The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613669The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613645The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613621The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613607The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613584The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613560The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613546The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613522The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613508The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613485The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613461The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613447The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613423The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613409The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613386The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613362The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613348The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
03700449613324The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended
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