FDA.reportPublic FDA data

Valeo Spacer System

Primary DI
M555110092023
Brand
Valeo Spacer System
Company
SINTX Technologies, Inc.
Model
B
Catalog number
11.009.2023
Device description
Valeo Corpectomy 17x14mm, 0°, 23mm Height
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
Sterile
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
M555110092023PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height23Millimeter
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
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
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
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
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
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