FDA.reportPublic FDA data

Yellowstone

Primary DI
B587XC11224040
Brand
Yellowstone
Company
SUMMIT SPINE LLC
Model
1
Catalog number
XC112240-4
Device description
11mm H x 22mm W x 40mm L x 4 degree XLIF Coronal Taper
Published
2019-08-13
Public version status
Update
Distribution status
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B587XC11224040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle4degree
Height11Millimeter
Length40Millimeter
Width22Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8772089272info@summitspineco.com

Regulatory Flags#

DUNS number
079539689
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5872011010Yellowstone120-11012018-03-28
B5872012010Yellowstone120-12012018-03-28
B5872013010Yellowstone120-13012018-03-28
B587C07184040Yellowstone1C071840-42019-08-02
B587C07184540Yellowstone1C071845-42019-08-02
B587C09184040Yellowstone1C091840-42019-08-02
B587C09184540Yellowstone1C091845-42019-08-02
B587C09185040Yellowstone1C091850-42019-08-02
B587C09185540Yellowstone1C091855-42019-08-02
B587C09186040Yellowstone1C091860-42019-08-02
B587C11184040Yellowstone1C111840-42019-08-02
B587C11184540Yellowstone1C111845-42019-08-02
B587C11185040Yellowstone1C111850-42019-08-10
B587C11185540Yellowstone1C111855-42019-08-10
B587C11186040Yellowstone1C111860-42019-08-10
B587C13184040Yellowstone1C131840-42019-08-10
B587C13184540Yellowstone1C131845-42019-08-10
B587C13185040Yellowstone1C131850-42019-08-10
B587C13185540Yellowstone1C131855-42019-08-10
B587C13186040Yellowstone1C131860-42019-08-10

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Primary DI, Brand, Company table
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