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Orion Sacroiliac Joint Fusion System

FDA UDI

Class II (US FDA UDI)

by Pantheon Spinal LLC

Identity

Trade Name
Orion Sacroiliac Joint Fusion System FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
Device Name
13mm x 50mm Implant FDA UDI
Model / Reference
1 FDA UDI
Description
13mm x 50mm Implant FDA UDI

Identifiers

Catalog Number
PS-M1350 FDA UDI
Primary DI / UDI-DI
B528PSM13500 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 50 Millimeter FDA UDI
Outer Diameter — 13 Millimeter FDA UDI

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

Orion Sacroiliac Joint Fusion System by Pantheon Spinal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pantheon Spinal LLC

Sources (1)

  • FDA UDI a6b72711-e531-40a8-8872-fd47f2d7de86 36 fields · synced May 30, 2026