Home GUDID M697X07901121 Silex Sacroiliac Joint Fusion System
Primary DI M697X07901121
Brand Silex Sacroiliac Joint Fusion System
Company Xtant Medical Holdings, Inc.
Model X079-0112
Device description FIXED PARALLEL PIN GUIDE
Published 2026-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name FZX Guide, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X07901121 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04250337121657 Working Tube with long lip Joimax GmbH FZX 2026-08-19 00810111225465 joint seeker Treace Medical Concepts, Inc. FZX 2026-08-17 06936666566724 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06936666566731 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278653161 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278653321 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278653475 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278653499 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278654793 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 06937278654809 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. FZX 2026-08-15 00810111225427 Targeter Treace Medical Concepts, Inc. FZX 2026-08-14 00810111225434 Targeter Treace Medical Concepts, Inc. FZX 2026-08-14 00190776411091 Millennium Avalign Technologies, Inc. FZX 2026-08-07 06438408012815 Inion CompressOn™ / Inion FreedomScrew™ Instrument Inion Oy FZX 2026-08-07 06438408012822 Inion CompressOn™ / Inion FreedomScrew™ Instrument Inion Oy FZX 2026-08-07 06438408012839 Inion CompressOn™ Instrument Inion Oy FZX 2026-08-07 00840606191838 Overwatch PCF SPINAL ELEMENTS, INC. FZX 2026-07-31 00840606191845 Overwatch PCF SPINAL ELEMENTS, INC. FZX 2026-07-31 00190376544496 Invictus ALPHATEC SPINE, INC. FZX 2026-07-30 03701089528054 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089542548 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089543316 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089543330 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089543354 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089543378 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03701089543682 AMPLITUDE AMPLITUDE SAS FZX 2026-07-29 03700569674335 Newclip Instruments NEWCLIP TECHNICS FZX 2026-07-28 03700569674342 Newclip Instruments NEWCLIP TECHNICS FZX 2026-07-28 03700569674281 Newclip Instruments NEWCLIP TECHNICS FZX 2026-07-27 03700569674298 Newclip Instruments NEWCLIP TECHNICS FZX 2026-07-27