Home GUDID 00841132187227 Response 4.5/5.0
Primary DI 00841132187227
Brand Response 4.5/5.0
Company ORTHOPEDIATRICS CORP.
Model 00-1600-2910
Catalog number 00-1600-2910
Device description 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 100MM - DOUBLE LEAD
Published 2025-05-20
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Single use true Product Codes# Code, Name table Code Name KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL NKB Thoracolumbosacral pedicle screw system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841132187227 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841132187227 00841132187227 841132187227 0841132187227
GMDN Terms# Term, Definition table Term Definition Spinal bone screw, non-bioabsorbable A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 796416191 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 00840536800039 3P Hip System 01-3002-1013 01-3002-1013 2026-06-09 00840536800046 3P Hip System 01-3002-2013 01-3002-2013 2026-06-09 00840536800053 3P Hip System 01-3002-3013 01-3002-3013 2026-06-09 00840536800060 3P Hip System 01-3035-0050 01-3035-0050 2026-06-09 00840536822741 Response 5.5/6.0 01-1300-6535 01-1300-6535 2026-05-30 00840536822758 Response 5.5/6.0 01-1300-6536 01-1300-6536 2026-05-30 00840536822543 Prone Perfect 03-1300-8801 03-1300-8801 2026-05-22 00840536822550 Prone Perfect 03-1300-8802 03-1300-8802 2026-05-22 00840536822567 Prone Perfect 03-1300-8803 03-1300-8803 2026-05-22 00840536822574 Prone Perfect 03-1300-8804 03-1300-8804 2026-05-22 00840536822581 Prone Perfect 03-1300-8805 03-1300-8805 2026-05-22 00840536822598 Prone Perfect 03-1300-8806 03-1300-8806 2026-05-22 00840536822604 Prone Perfect 03-1300-8807 03-1300-8807 2026-05-22 00840536822611 Prone Perfect 03-1300-8808 03-1300-8808 2026-05-22 00840536822628 Prone Perfect 03-1300-8809 03-1300-8809 2026-05-22 00840536822635 Prone Perfect 03-1300-8810 03-1300-8810 2026-05-22 00840536822642 Prone Perfect 03-1300-8811 03-1300-8811 2026-05-22 00841132199244 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6000-S 00-1200-6000-S 2026-05-13 00841132199251 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6001-S 00-1200-6001-S 2026-05-13 00841132199268 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6002-S 00-1200-6002-S 2026-05-13
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