AccessGUDID - DEVICE: Silex Sacroiliac Joint Fusion System (M697X07900031)

GUDID

Device Identifier (DI) Information

Brand Name: Silex Sacroiliac Joint Fusion System
Version or Model: X079-0003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697X07900031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: STERILIZATION CASE, SILEX

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?
58849	Sacroiliac joint transarticular fixation/arthrodesis implantation kit	A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRP	TRAY, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 13814ed7-a17b-4134-9d1a-21834317e5f7
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: August 31, 2015