FDA.report

Orion Sacroiliac Joint Fusion System

Primary DI
B528PSN0160
Brand
Orion Sacroiliac Joint Fusion System
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
PS-N016
Device description
11mm Drill, Cannulated
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
false

Related Records

Contact Domains

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B528PSN0160PrimaryHIBCC0

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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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B528XL14183080Yellowstone1XL141830-82021-10-07
B528XL14183580Yellowstone1XL141835-82021-10-07
B528XL14184080Yellowstone1XL141840-82021-10-07
B528XL14184580Yellowstone1XL141845-82021-10-07
B528XL14185080Yellowstone1XL141850-82021-10-07
B528XL14185580Yellowstone1XL141855-82021-10-07
B528XL10184080Yellowstone1XL101840-82021-10-02
B528XL10184580Yellowstone1XL101845-82021-10-02
B528XL10185080Yellowstone1XL101850-82021-10-02
B528XL10185580Yellowstone1XL101855-82021-10-02
B528XL10186080Yellowstone1XL101860-82021-10-02

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