Home GUDID 07290014381254 ProMIS™ Fixation System
Primary DI 07290014381254
Brand ProMIS™ Fixation System
Company PREMIA SPINE LTD
Model 87511
Device description Pre Bent Rod Ø6.0x250mm Blunt Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
Published 2026-05-25
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 true Product Codes# Code, Name table Code Name NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290014381254 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290014381254 07290014381254 7290014381254
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system rod An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
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 649220779 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 true 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 07290115932492 Tower ST 88606 2026-06-01 07290115932751 Alignment Gauge Medium 86202 2026-06-01 07290115932898 Cannulated Screwdriver External sleeve 86513 2026-06-01 07290115934076 Tower ST Long Window 88974 2026-06-01 07290115935622 Cannulated Screwdriver Inner Shaft Short 88264 2026-06-01 07290115935639 Cannulated Screwdriver Handle Assy Short 88265 2026-06-01 07290115935646 Cannulated Screwdriver External sleeve Short 88266 2026-06-01 07290115935653 Cannulated Screwdriver Handle Assy XL 87245 2026-06-01 07290115935660 Cannulated Screwdriver Inner Shaft XL 87154 2026-06-01 07290115935837 MIS Tower Guide 86261N 2026-06-01 07290014381261 ProMIS™ Fixation System 87512 2026-05-25 07290115935615 Counter Torque ST 83142N 2026-05-25 07290115932553 VersaLink Bender 82584 2024-10-01 07290115935479 Rod Bender 86297 2024-10-01 07290014381223 SST 316 LVM, L=470, Ø1.5 over the K-Wire 87851 2024-09-05 07290115934816 K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA 87302 2024-09-05 07290014381148 SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill 87447 2024-09-05 07290014381155 SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique 87209 2024-09-05 07290014381162 SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire 87208 2024-09-05 07290014381186 SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked) 87364 2024-09-05
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