AccessGUDID - DEVICE: SI-LUTION Sacroiliac Joint Fusion System (B648C6151300)

GUDID

Device Identifier (DI) Information

Brand Name: SI-LUTION Sacroiliac Joint Fusion System
Version or Model: C615-130-275
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CURITEVA, INC.

Primary DI Number: B648C6151300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074575332 *Terms of Use

Device Description: EXCHANGE PIN, 3.2 X 500mm

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:	No
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?
63819	Spinal guidewire	A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191810	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
Depth: 500 Millimeter
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: 23e551f8-4954-4ca1-9369-c251434d75a3
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024