AccessGUDID - DEVICE: Sacroiliac Joint Fusion System (M719GSISD135400)

GUDID

Device Identifier (DI) Information

Brand Name: Sacroiliac Joint Fusion System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GSI-SD13540
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GSISD135400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: 13.5mm x 40mm SI Screw - Dual Thread

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?
62399	Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile	A non-sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191748	000

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: 13.5 Millimeter
Length: 40 Millimeter

Device Record Status

Public Device Record Key: e505854c-6f97-4c0c-ba90-838bd2b5c16e
Public Version Date: December 18, 2019
Public Version Number: 1
DI Record Publish Date: December 10, 2019