FDA.reportPublic FDA data

Valeo Interbody Fusion Device

Primary DI
M555112091109
Brand
Valeo Interbody Fusion Device
Company
SINTX Technologies, Inc.
Model
A
Catalog number
11.209.1109
Device description
C+CSC with Lumen 16x12, 0°, 9mm
Published
2018-06-08
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M555112091109PrimaryHIBCC0

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
Height9Millimeter
Length12Millimeter
Width16Millimeter

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

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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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