FDA.reportPublic FDA data

Valeo Spacer System

Primary DI
M555110022011
Brand
Valeo Spacer System
Company
SINTX Technologies, Inc.
Model
C
Catalog number
11.002.2011
Device description
Valeo VBR - C, 17x14, 0°, 11mm
Published
2017-12-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M555110022011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11Millimeter
Length17Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-839-3500customerservice@amedica.com

Regulatory Flags#

DUNS number
028629553
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G817103151100SiNAPTIC Osteotomy Wedge SystemInserter - Rev. 0103-15-11002026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemTamp - Rev. 0103-15-12002026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216052026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216062026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216072026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216082026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216102026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216122026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418052026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418062026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418072026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418082026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418102026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418122026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemEvans Wedge - Rev. 1S-101-1818062026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216052026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216062026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216072026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216082026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216102026-04-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00841732128231VALEO VBRCTL Medical CorporationMQP2023-09-27
00841732128248VALEO VBRCTL Medical CorporationMQP2023-09-27
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08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09