FDA.reportPublic FDA data

Yellowstone

Primary DI
B528XL10187080
Brand
Yellowstone
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
XL101870-8
Device description
Lateral Implant 10mm H x 18mm W x 70mm L - 8 degree Lordotic
Published
2021-10-02
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170572000Summit Spine Yellowstone Lumbar Interbody Fusion SystemSummit Spine2017-04-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B528XL10187080PrimaryHIBCC0

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
Angle8degree
Height10Millimeter
Length70Millimeter
Width18Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123083488info@pantheon-spinal.com

Regulatory Flags#

DUNS number
071012634
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B528100800001003020EPIPHANY11008-0000 1003-022018-01-21
B528100900001003030EPIPHANY11009-0000 1003-032018-01-21
B528101000000EPIPHANY11010-00002018-01-21
B528101100000EPIPHANY11011-00002018-01-21
B528101200000EPIPHANY11012-00002018-01-21
B528PSM11W0Orion Sacroiliac Joint Fusion System1PS-M11W2020-10-12
B528PSM13W0Orion Sacroiliac Joint Fusion System1PS-M13W2020-10-12
B528100213010Yellowstone11002-13012018-05-26
B528100213020Epiphany11002-13022018-05-26
B528100310011022110Epiphany11003-1001 1022-112018-05-26
B528100310021022120Epiphany11003-1002 1022-122018-05-26
B528100418011023010EPIPHANY11004-1801 1023-012018-01-21
B528100418021023020EPIPHANY11004-1802 1023-022018-01-21
B528100418041023040EPIPHANY11004-1804 1023-042018-01-21
B528XL12184080Yellowstone1XL121840-82021-10-07
B528XL12184580Yellowstone1XL121845-82021-10-07
B528XL12185080Yellowstone1XL121850-82021-10-07
B528XL12185580Yellowstone1XL121855-82021-10-07
B528XL12186080Yellowstone1XL121860-82021-10-07
B528XL12186580Yellowstone1XL121865-82021-10-07

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Primary DI, Brand, Company table
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B707602003US0DUALX DUAL PORTAL PITUITARY STRAIGHT 2.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
B707BHP18042US0DUALX DUAL PORTAL BALL HOOKAMPLIFY SURGICAL, INC.MAX2026-09-28
B707QU332130US0DUALX DUAL PORTAL CURETTE UP 3.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
B707UNH2002US0DUALX DUAL PORTAL ROTATORY HANDLEAMPLIFY SURGICAL, INC.MAX2026-09-28
B707UNH4020US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 2.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
B707UNH4030US0DUALX DUAL PORTAL ROTATORY KERRISON PUNCH 3.0mmAMPLIFY SURGICAL, INC.MAX2026-09-28
B707USCH2US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR CLAMPAMPLIFY SURGICAL, INC.MAX2026-09-28
B707USCH3US0DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR FUSIONAMPLIFY SURGICAL, INC.MAX2026-09-28
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