Home GUDID B047106090 SpineNet SSP®
Primary DI B047106090
Brand SpineNet SSP®
Company SPINENET, LLC
Model SSP® Screw Driver
Catalog number 106-09
Device description SpineNet SSP®, Screw Driver-Instrument
Published 2021-12-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B047106090 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 792052321 Device count 1 DM exempt true 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 B047124110 SpineNet SSP® SSP® Plate 1-2411 2021-12-14 B047126130 SpineNet SSP® SSP® Plate 1-2613 2021-12-14 B047242290 SpineNet SSP® SSP® Plate 2-4229 2021-12-14 B047245320 SpineNet SSP® SSP® Plate 2-4532 2021-12-14 B047248350 SpineNet SSP® SSP® Plate 2-4835 2021-12-14 B047FB42120 SpineNet SSP® SSP® Fixed Screw FB4212 2021-12-14 B047FB42140 SpineNet SSP® SSP® Fixed Screw FB4214 2021-12-14 B047FB46120 SpineNet SSP® SSP® Fixed Screw FB4612 2021-12-14 B047FB46140 SpineNet SSP® SSP® Fixed Screw FB4614 2021-12-14 B047106010 SpineNet SSP® SpineNet SSP® Bone Awl 106-01 2022-01-12 B047106040 SpineNet SSP® SpineNet SSP® Bone Tap 106-04 2022-01-12 B047106060 SpineNet SSP® SpineNet SSP® Small AO Chuck Handle 106-06 2022-01-12 B047106070 SpineNet SSP® SpineNet SSP® Fixed Drill Guide 106-07 2022-01-12 B047106080 SpineNet SSP® SpineNet SSP® Variable Drill Guide 106-08 2022-01-12 B047106100 SpineNet SSP® SpineNet SSP® Cam Torque Lmtr Handle 106-10 2022-01-12 B047106110 SpineNet SSP® SpineNet SSP® Cam-Lock Driver 106-11 2022-01-12 B047106120 SpineNet SSP® SpineNet SSP® Plate Bender 106-12 2022-01-12 B047106020 SpineNet SSP® SSP® Drill Bit 106-02 2021-12-13 B04710603120 SpineNet SSP® SSP® Drill Sleeve, 12mm 106-03-12 2021-12-13 B04710603140 SpineNet SSP® SSP® Drill Sleeve, 14mm 106-03-14 2021-12-13
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