Response Spine 5.5/6.0 System 00-1003-6001

GUDID 00841132100110

5.5 ROD COCR 500MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132100110
• NIH Device Record Key: be55aac9-2be4-48ce-992e-d84a4d93d468
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response Spine 5.5/6.0 System
• Version Model Number: 00-1003-6001
• Catalog Number: 00-1003-6001
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132100110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150600

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-30

On-Brand Devices [Response Spine 5.5/6.0 System]

• 00841132131732: Half Size Poly Reduction Pedicle Screw Case
• 00841132131725: Half Size Poly Pedicle Screw Case
• 00841132131718: Half Size Uni Reduction Pedicle Screw Case
• 00841132131701: Half Size Uni Pedicle Screw Case
• 00841132131695: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 85mm Length
• 00841132131688: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 80mm Length
• 00841132131671: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 75mm Length
• 00841132131664: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 70mm Length
• 00841132131657: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 65mm Length
• 00841132131640: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 60mm Length
• 00841132131633: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 55mm Length
• 00841132131626: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 50mm Length
• 00841132131619: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 45mm Length
• 00841132131602: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 40mm Length
• 00841132131596: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 35mm Length
• 00841132131589: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 30mm Length
• 00841132131572: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 25mm Length
• 00841132131565: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 20mm Length
• 00841132131558: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 75mm Length
• 00841132131541: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 70mm Length
• 00841132131534: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 65mm Length
• 00841132131527: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 60mm Length
• 00841132131510: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 55mm Length
• 00841132131503: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 50mm Length
• 00841132131497: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 45mm Length
• 00841132131480: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 40mm Length
• 00841132131473: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 35mm Length
• 00841132131466: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 30mm Length
• 00841132131459: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 25mm Length
• 00841132131442: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 20mm Length
• 00841132131435: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 40mm Length
• 00841132131428: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 35mm Length
• 00841132131411: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 30mm Length
• 00841132131404: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 25mm Length
• 00841132131398: 5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 20mm Length
• 00841132131381: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 85mm Length
• 00841132131374: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 80mm Length
• 00841132131367: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 75mm Length
• 00841132131350: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 70mm Length
• 00841132131343: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 65mm Length
• 00841132131336: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 60mm Length
• 00841132131329: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 55mm Length
• 00841132131312: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 50mm Length
• 00841132131305: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 45mm Length
• 00841132131299: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 40mm Length
• 00841132131282: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 35mm Length
• 00841132131275: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 30mm Length
• 00841132131268: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 35mm Length
• 00841132131251: 5.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 20mm Length
• 00841132131244: 5.5/6.0 Polyaxial Pedicle Screws - Ø5.5mm, 75mm Length