Response 5.5/6.0 Cannulated Screw System

GUDID 00840194417778

5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 45mm

ORTHOPEDIATRICS CORP.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840194417778
• NIH Device Record Key: bef6e136-fb86-47f1-86cf-a58eb07a9a16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 5.5/6.0 Cannulated Screw System
• Version Model Number: 00-1301-3945
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194417778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222105

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

[00840194417778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [Response 5.5/6.0 Cannulated Screw System]

• 00840194422376: 5.5/6.0 Cannulated Reduction Screw Instrument Tray 2
• 00840194422369: 5.5/6.0 Cannulated Reduction Screw Instrument Tray 1
• 00840194422345: 5.5/6.0 Cannulated Polyaxial Reduction Screw Caddy 1
• 00840194422338: 5.5/6.0 Cannulated Screw Instrument Tray 3
• 00840194422307: 5.5/6.0 Cannulated Lenke Probe Insert
• 00840194417877: 5.5/6.0 Cannulated Reduction Pedicle Screw Driver, T15, Zimmer Hudson Connect
• 00840194417860: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 100mm
• 00840194417853: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 90mm
• 00840194417846: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 80mm
• 00840194417839: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 75mm
• 00840194417822: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 70mm
• 00840194417815: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 65mm
• 00840194417808: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 60mm
• 00840194417792: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 55mm
• 00840194417785: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 50mm
• 00840194417778: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 45mm
• 00840194417761: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 9mm x 40mm
• 00840194417754: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 100mm
• 00840194417747: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 90mm
• 00840194417730: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 80mm
• 00840194417723: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 75mm
• 00840194417716: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 70mm
• 00840194417709: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 65mm
• 00840194417693: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 60mm
• 00840194417686: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 55mm
• 00840194417679: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 50mm
• 00840194417662: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 45mm
• 00840194417655: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 8mm x 40mm
• 00840194417648: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 100mm
• 00840194417631: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 90mm
• 00840194417624: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 80mm
• 00840194417617: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 75mm
• 00840194417600: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 70mm
• 00840194417594: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 65mm
• 00840194417587: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 60mm
• 00840194417570: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 55mm
• 00840194417563: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 50mm
• 00840194417556: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 45mm
• 00840194417549: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 7mm x 40mm
• 00840194417532: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 90mm
• 00840194417525: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 80mm
• 00840194417518: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 75mm
• 00840194417501: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 70mm
• 00840194417495: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 65mm
• 00840194417488: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 60mm
• 00840194417471: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 55mm
• 00840194417464: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 50mm
• 00840194417457: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 45mm
• 00840194417440: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6.5mm x 40mm
• 00840194417433: 5.5/6.0 Cannulated Polyaxial Reduction Screw, 6mm x 80mm