AccessGUDID - DEVICE: SI-LUTION Sacroiliac Joint Fusion System (B648C6158000)

GUDID

Device Identifier (DI) Information

Brand Name: SI-LUTION Sacroiliac Joint Fusion System
Version or Model: C615-800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CURITEVA, INC.

Primary DI Number: B648C6158000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074575332 *Terms of Use

Device Description: GRAFT PACKER

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?
47743	Bone graft packing block	A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable 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
No Device Sizes

Device Record Status

Public Device Record Key: f7e99b0e-c13f-4e45-b796-a8c36d88fb81
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024