Home GUDID M697C01000880 Fortex Pedicle Screw System
Primary DI M697C01000880
Brand Fortex Pedicle Screw System
Company X-SPINE SYSTEMS, INC.
Model C010-0088
Device description Special Instrument Straight Lenke Probe
Published 2021-04-30
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 HXB Probe MNH Orthosis, spondylolisthesis spinal fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HXB Probe Orthopedic 1 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697C01000880 Direct Marking HIBCC 0 M697C01000881 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610042587 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 00840606191302 Primus SPINAL ELEMENTS, INC. HXB 2026-09-22 00840606191319 Primus SPINAL ELEMENTS, INC. HXB 2026-09-22 B7685451520 Buxton BioMedical BUXTON BIOMEDICAL, INC. HXB 2023-07-06 00613994230676 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. HXB 2022-10-07 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147806 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation MNH 2014-12-08 04546540147912 XIA I Stryker Corporation MNH 2014-12-08 04546540147929 XIA I Stryker Corporation MNH 2014-12-08 04546540147936 XIA I Stryker Corporation MNH 2014-12-08 04546540147974 XIA I Stryker Corporation MNH 2014-12-08 04546540147981 XIA I Stryker Corporation MNH 2014-12-08 04546540147998 XIA I Stryker Corporation MNH 2014-12-08 04546540148001 XIA II Stryker Corporation MNH 2014-12-08 04546540148018 XIA II Stryker Corporation MNH 2014-12-08 04546540148025 XIA II Stryker Corporation MNH 2014-12-08 04546540148735 XIA II Stryker Corporation MNH 2014-12-08 04546540148742 XIA II Stryker Corporation MNH 2014-12-08 04546540148759 XIA II Stryker Corporation MNH 2014-12-08 04546540148766 XIA II Stryker Corporation MNH 2014-12-08 04546540148773 XIA II Stryker Corporation MNH 2014-12-08 04546540148780 XIA II Stryker Corporation MNH 2014-12-08 04546540148797 XIA II Stryker Corporation MNH 2014-12-08 04546540148803 XIA II Stryker Corporation MNH 2014-12-08
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