Home GUDID 00840194495158 Response 5.5/6.0
Primary DI 00840194495158
Brand Response 5.5/6.0
Company ORTHOPEDIATRICS CORP.
Model 01-1300-6500
Catalog number 01-1300-6500
Device description 5.5/6.0 Response Quick-Draw Reducer
Published 2025-12-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00840194495158 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 00840194495158 00840194495158 840194495158 0840194495158
GMDN Terms# Term, Definition table Term Definition Orthopaedic rod reducer A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
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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