Home GUDID 03662663002516 Easyspine
Primary DI 03662663002516
Brand Easyspine
Company LDR Spine Usa, Inc.
Model ES322T
Device description ALPHA LEFT PEDICLE HOOK
Published 2015-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
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 03662663002516 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662663002516 03662663002516 3662663002516
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An assembly of 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. Sterile disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 615789729 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21
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