Home GUDID B07510000575500 Dark Star
Primary DI B07510000575500
Brand Dark Star
Company REPUBLIC SPINE
Model 1
Catalog number DSR-7550
Device description Reduction Screw
Published 2016-08-31
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MNH Orthosis, Spondylolisthesis Spinal Fixation NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B07510000575500 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 50 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 061891717 Device count 1 DM exempt false Premarket exempt false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B0751002600 Dark Star 1 DS0001 2016-09-16
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10888857598164 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598171 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598188 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598195 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598201 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598218 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598225 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598232 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 10888857598249 Xia® 3 System - Serrato® VB Spine LLC NKB 2026-07-24 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-09-17 00613994887955 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-09-17 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147257 XIA II Stryker Corporation NKB 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation NKB 2014-12-08 04546540147806 XIA II Stryker Corporation NKB 2014-12-08 04546540147806 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation MNH 2014-12-08 04546540147905 XIA II Stryker Corporation NKB 2014-12-08 04546540147912 XIA I Stryker Corporation NKB 2014-12-08 04546540147912 XIA I Stryker Corporation MNH 2014-12-08 04546540147929 XIA I Stryker Corporation MNH 2014-12-08
rspine.com