AccessGUDID - DEVICE: Orion Sacroiliac Joint Fusion System (B528PSM11W0)

GUDID

Device Identifier (DI) Information

Brand Name: Orion Sacroiliac Joint Fusion System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS-M11W
Company Name: PANTHEON SPINAL, LLC

Primary DI Number: B528PSM11W0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071012634 *Terms of Use

Device Description: 11mm Washer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: 73f013ef-007b-4cfd-aa12-9afdf9159b9e
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: October 12, 2020