SUPSTANCE Small 100114842

GUDID 00370049613881

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 ID	00370049613881
NIH Device Record Key	2286ab9a-5219-4398-931f-1c1bed25fba5
Commercial Distribution Status	In Commercial Distribution
Brand Name	SUPSTANCE Small
Version Model Number	100114842
Catalog Number	100114842
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

Angle	8 degree
Angle	8 degree
Angle	8 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370049613881 [Primary]

FDA Product Code

MQP	Spinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00370049613881]

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 Small]

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