AccessGUDID - DEVICE: TransFasten - LSF (Lateral Sacroiliac Fusion System) (M73910110300)

GUDID

Device Identifier (DI) Information

Brand Name: TransFasten - LSF (Lateral Sacroiliac Fusion System)
Version or Model: 10-1-1030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CAPTIVA SPINE, INC.

Primary DI Number: M73910110300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836975784 *Terms of Use

Device Description: Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)

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?
61485	Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated	An 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.	Active	true
58733	Sacroiliac joint intra-articular arthrodesis implant	An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170475	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: 056e25c9-8b20-4007-a5a5-bf9fe5040e1f
Public Version Date: March 11, 2024
Public Version Number: 1
DI Record Publish Date: March 01, 2024