Home GUDID 00613994887955 TSRH® Spinal System
Primary DI 00613994887955
Brand TSRH® Spinal System
Company MEDTRONIC SOFAMOR DANEK, INC.
Model 83575209H
Device description SCREW 83575209H TSRH OSTEOGRIP HA
Published 2015-09-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL MNH Orthosis, spondylolisthesis spinal fixation MNI ORTHOSIS, SPINAL PEDICLE FIXATION NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00613994887955 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00613994887955 00613994887955 613994887955 0613994887955
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Outer Diameter 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 830350380 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840606186544 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00840606186551 OMEGA XP SPINAL ELEMENTS, INC. KWP 2026-09-22 00613994738646 ZEPHIR® Anterior Cervical System MEDTRONIC SOFAMOR DANEK, INC. KWP 2019-03-07 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 2015-08-05 00885074494722 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 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 00613994568311 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. NKB 2015-08-05 00613994568823 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNH 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 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. MNI 2015-08-05 00613994888143 TSRH® Spinal System MEDTRONIC SOFAMOR DANEK, INC. KWP 2015-08-05 04546540147257 XIA II Stryker Corporation KWP 2014-12-08 04546540147257 XIA II Stryker Corporation NKB 2014-12-08 04546540147257 XIA II Stryker Corporation MNH 2014-12-08 04546540147257 XIA II Stryker Corporation MNI 2014-12-08 04546540147769 XIA II Stryker Corporation KWP 2014-12-08 04546540147769 XIA II Stryker Corporation MNH 2014-12-08 04546540147769 XIA II Stryker Corporation NKB 2014-12-08 04546540147769 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation MNI 2014-12-08 04546540147806 XIA II Stryker Corporation KWP 2014-12-08 04546540147806 XIA II Stryker Corporation NKB 2014-12-08
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