Home GUDID H981046512750 NA
Primary DI H981046512750
Brand NA
Company Synthes GmbH
Model 04.651.275
Catalog number 04651275
Device description 5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/75MM
Published 2015-09-14
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 true Product Codes# Code, Name table Code Name MNH Orthosis, spondylolisthesis spinal fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034751702 Primary GS1 0 H981046512750 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034751702 10705034751702
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 486711679 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 07290115935677 XL Adaptor PREMIA SPINE LTD MNH 2026-10-20 07290115935905 XL Screwdriver CM PREMIA SPINE LTD MNH 2026-10-20 07290115935912 Screwdriver CM PREMIA SPINE LTD MNH 2026-10-20 07290115935929 Tube for K-wire over a k-wire technique 470mm (Nitinol) PREMIA SPINE LTD MNH 2026-10-20 07290115935936 Tube for XL K-Wire 450mm PREMIA SPINE LTD MNH 2026-10-20 07290115935943 Tube for K-Wires of 470mm PREMIA SPINE LTD MNH 2026-10-20 07290115935950 Tube for K-Wires up to 340mm PREMIA SPINE LTD MNH 2026-10-20 07290115932874 Cannulated Screwdriver inner shaft PREMIA SPINE LTD MNH 2026-10-18 07290115932881 Cannulated Screwdriver Handle Assy PREMIA SPINE LTD MNH 2026-10-18 M697X07300251 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X073825100DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382560DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382565DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382570DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382575DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382580DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382585DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382590DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 M697X07382595DL1 Xpress Minimally Invasive Pedicle Screw System Xtant Medical Holdings, Inc. MNH 2026-10-14 08806364689439 Kora Spinal System Medyssey Co., Ltd. MNH 2026-10-01 08806364690077 Kora Spinal System Medyssey Co., Ltd. MNH 2026-10-01 00840916152413 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152420 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152437 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152444 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152529 TALON SPINAL ELEMENTS MNH 2020-04-14 00840916152536 TALON SPINAL ELEMENTS MNH 2020-04-14 10888857001428 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05 10888857001435 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05 10888857001459 DENALI® MI Spinal System VB Spine LLC MNH 2018-11-05
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