FDA.report

Orion Sacroiliac Joint Fusion System

Primary DI
B528PSN0190
Brand
Orion Sacroiliac Joint Fusion System
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS-N019
Device description
3.2mm Steinmann Pin, Round, 280mm
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
B528PSN0190PrimaryHIBCC0

GMDN Terms

TermDefinition
Intraoperative bone pin/screw, non-sterileA small non-sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device intended to be sterilized prior to use.

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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