FDA.reportPublic FDA data

Yellowstone

Primary DI
B587XL1416350
Brand
Yellowstone
Company
SUMMIT SPINE LLC
Model
1
Catalog number
XL141635
Device description
14mm H x 16mm W x 35mm L Lateral Implant
Published
2019-11-03
Public version status
New
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
B587XL1416350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma hominis nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Mycoplasma hominis bacteria in a clinical specimen, using a nucleic acid technique (NAT).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height14Millimeter
Length35Millimeter
Width16Millimeter

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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B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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