AccessGUDID - DEVICE: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (B74240308210)

GUDID

Device Identifier (DI) Information

Brand Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Version or Model: 40308-21
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 40308-21
Company Name: TENON MEDICAL, INC.

Primary DI Number: B74240308210
Issuing Agency: HIBCC
Commercial Distribution End Date: December 17, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 117014636 *Terms of Use

Device Description: 10mm Drill

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?
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 [?]
K180818	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: 10 Millimeter

Device Record Status

Public Device Record Key: 322ab2d5-2cd2-4295-bd1c-0d593cf01c85
Public Version Date: December 17, 2021
Public Version Number: 4
DI Record Publish Date: June 12, 2020