Response 5.5/6.0 Spine System 00-1350-1845

GUDID 00841132175255

8mm x 45mm 5.5/6.0 UNIAXIAL REDUCTION SINGLE LEAD PEDICLE SCREW ASSEMBLY

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132175255
• NIH Device Record Key: 77558a3f-4298-45bb-98ae-ef8ef9807ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 5.5/6.0 Spine System
• Version Model Number: 00-1350-1845
• Catalog Number: 00-1350-1845
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132175255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181390

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00841132175255]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-13
• Device Publish Date: 2020-03-05

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

• 00084113213712: SET SCREW TORQUE LIMITER, GRAY T-HANDLE 13 N-m
• 00841132177679: 5.5/6.0 - 40 DEG. OFFSET HOOK, Right 6.5mm
• 00841132177662: 5.5/6.0 - 40 DEG. OFFSET HOOK, Left 6.5mm
• 00841132177655: 5.5/6.0 - 40 DEG. OFFSET HOOK, Right 8mm
• 00841132177648: 5.5/6.0 - 40 DEG. OFFSET HOOK, Left 8mm
• 00841132183694: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length
• 00841132183687: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length
• 00841132183670: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length
• 00841132183663: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length
• 00841132183656: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length
• 00841132183649: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length
• 00841132183632: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length
• 00841132183625: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length
• 00841132183618: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length
• 00841132183601: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length
• 00841132183595: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length
• 00841132183588: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length
• 00841132183571: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length
• 00841132183564: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length
• 00841132183557: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 75mm Length
• 00841132183540: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 70mm Length
• 00841132183533: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 65mm Length
• 00841132183526: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 60mm Length
• 00841132183519: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 55mm Length
• 00841132183502: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 50mm Length
• 00841132183496: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 45mm Length
• 00841132183489: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 40mm Length
• 00841132183472: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 35mm Length
• 00841132183465: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 30mm Length
• 00841132183458: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 25mm Length
• 00841132183441: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 20mm Length
• 00841132183434: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 40mm Length
• 00841132183427: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 35mm Length
• 00841132183410: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 30mm Length
• 00841132183403: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 25mm Length
• 00841132183397: 5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 20mm Length
• 00841132183380: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length
• 00841132183373: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length
• 00841132183366: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length
• 00841132183359: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length
• 00841132183342: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length
• 00841132183335: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length
• 00841132183328: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length
• 00841132183311: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length
• 00841132183304: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length
• 00841132183298: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length
• 00841132183281: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length
• 00841132183274: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length
• 00841132183267: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length
• 00841132183250: 5.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length