FDA.reportPublic FDA data

Orion Sacroiliac Joint Fusion System

Primary DI
B528PSM11W0
Brand
Orion Sacroiliac Joint Fusion System
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS-M11W
Device description
11mm Washer
Published
2020-10-12
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
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B528PSM11W0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter11Millimeter

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
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
B528XL12187080Yellowstone1XL121870-82021-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143399Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143405Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143412Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143429Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143436Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143443Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143450Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146079Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146086Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146093Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146109Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146116Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146123Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146130Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146147Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146154Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146161Firebird SI FusionOrthofix US LLCOUR2026-07-17