Home GUDID M697X079008410 Silex Sacroiliac Joint Fusion System
Primary DI M697X079008410
Brand Silex Sacroiliac Joint Fusion System
Company Xtant Medical Holdings, Inc.
Model X079-0084-1
Device description STEINMANN PIN DEPTH GAGE/GUIDE BLOCK
Published 2015-08-31
Public version status Update
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 HTJ GAUGE, DEPTH
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTJ Gauge, Depth Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X079008410 Direct Marking HIBCC 0 M697X079008411 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implantation kit A collection of non-sterile 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.
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 06974940307243 endophix Suzhou Endophix Co., Ltd. HTJ 2026-06-23 08809513720045 SAEHAN Hydraulic Pinch Gauge Saehan Corporation HTJ 2026-05-18 08809513720359 SAEHAN Mechanical Pinch Gauge Saehan Corporation HTJ 2026-05-18 08800322750001 AnyPlus® GS Medical Co., Ltd. HTJ 2026-04-21 10850070500484 Cannulated Depth Guage CURVAFIX, INC. HTJ 2025-10-22 08800071006862 Surgical Instrument OSTEONIC CO.,Ltd. HTJ 2025-06-24 08809539690667 Surgical Instrument OSTEONIC CO.,Ltd. HTJ 2025-06-24 10840199512703 Depth Gauge KOROS U.S.A., INC. HTJ 2024-12-31 10840199513670 Multi Level Black Belt Depth Gauge KOROS U.S.A., INC. HTJ 2024-12-31 10885862573483 EPIC Exactech, Inc. HTJ 2024-01-08 07708604560472 SAMPEDRO INDUSTRIAS MEDICAS SAMPEDRO S A S HTJ 2023-01-18 08055727374561 DEPTH GAUGE 9 mm HPF SRL HTJ 2022-12-09 08055727374578 DEPTH GAUGE 9 mm HPF SRL HTJ 2022-12-09 10603295550273 INHANCE DEPUY (IRELAND) HTJ 2022-12-09 10855068008607 Implant Selection Device CURVAFIX, INC. HTJ 2022-12-05 10855068008331 Implant Selection Device CURVAFIX, INC. HTJ 2021-12-02 08800089415298 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089415328 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089417230 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089418350 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089418374 INLET System Surgical Instrument Jeil Medical Corporation HTJ 2021-11-18 08800089402762 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 08800089402779 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 08800089402830 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2021-05-28 M684E15000401 EVOLUTION Microport Orthopedics Inc. HTJ 2019-12-23 00815362021453 Slimplicity Anterior Cervical Plate System PRECISION SPINE, INC. HTJ 2019-04-01 08806390873765 VERUM System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-17 08806390863247 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05 08806390865869 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05 08806390867764 Summa Orthopaedics System Surgical Instrument Jeil Medical Corporation HTJ 2018-12-05
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