FDA.reportPublic FDA data

Yellowstone

Primary DI
B5872010030
Brand
Yellowstone
Company
SUMMIT SPINE LLC
Model
1
Catalog number
20-1003
Device description
Dilator - Large
Published
2018-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B5872010030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fascial tissue dilator, reusableA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or surgical procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and made of metal (e.g., stainless steel). It is typically used for the dilatation of fascial tissue around peripheral vasculature, puncture sites, and various ducts. This is a reusable device.

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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00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
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