FDA.report

Orion Sacroiliac Joint Fusion System

Primary DI
B528PSM11350
Brand
Orion Sacroiliac Joint Fusion System
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS-M1135
Device description
11mm x 35mm Implant
Published
2020-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B528PSM11350PrimaryHIBCC0

GMDN Terms

TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterileA non-sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Device Sizes

TypeValueUnit
Length35Millimeter
Outer Diameter11Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
5123083488info@pantheon-spinal.com

Regulatory Flags

DUNS number
071012634
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B528XL10185580Yellowstone1XL101855-82021-10-02
B528XL10186080Yellowstone1XL101860-82021-10-02

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