FDA.report

Orion Sacroiliac Joint Fusion System

Primary DI
B528PSM13W0
Brand
Orion Sacroiliac Joint Fusion System
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS-M13W
Device description
13mm Washer
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
B528PSM13W0PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Outer Diameter13Millimeter

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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