Home GUDID B07315BSC05050 NIDO Pedicle Screw System
Primary DI B07315BSC05050
Brand NIDO Pedicle Screw System
Company Kalitec Direct LLC
Model 15-BSC-0505
Catalog number 15-BSC-0505
Device description Bone Screw, Solid, Cortical, 10.5 x 105mm
Published 2023-10-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
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 B07315BSC05050 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 041956211 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B073DRK0100300 Cosmolock DR-K01-0030 DR-K01-0030 2021-03-16 B073K0730000 Matira 07-K07-3000 07-K07-3000 2020-01-03 B07307CPR01181 Matira Anterior Cervical Plate System 07-CPR-0118 07-CPR-0118 2017-10-31 B07307CPR01191 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0119 07-CPR-0119 2017-10-31 B07307CPR01201 MATIRA ANTERIOR CERVICAL PLATE SYSTEM 07-CPR-0120 07-CPR-0120 2017-10-31 B07307CPR01211 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0121 01-CPR-0121 2017-10-31 B07307CPR01221 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0122 07-CPR-0122 2017-10-31 B07307CPR01241 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0124 07-CPR-0124 2017-10-31 B07307CPR01261 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0126 07-CPR-0126 2017-10-31 B07307CPR01281 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0128 07-CPR-0128 2017-10-31 B07307CPR01301 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0130 07-CPR-0130 2017-10-31 B07307CPR01321 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0132 07-CPR-0132 2017-10-31 B07307CPR01341 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0134 07-CPR-0134 2017-10-31 B07307CPR02321 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0232 07-CPR-0232 2017-10-31 B07307CPR02341 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0234 07-CPR-0234 2017-10-31 B07307CPR02361 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0236 07-CPR-0236 2017-10-31 B07307CPR02381 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0238 07-CPR-0238 2017-10-31 B07307CPR02401 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0240 07-CPR-0240 2017-10-31 B07307CPR02421 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0242 07-CPR-0242 2017-10-31 B07307CPR02441 MATIRA ANTERIOR CERVICAL SYSTEM 07-CPR-0244 07-CPR-0244 2017-10-31
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