Response Navigation 01-1800-6043

GUDID 00840194462785

5.5/6.0 Cannulated Reduction Pedicle Screw Driver Navigation

ORTHOPEDIATRICS CORP.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00840194462785
• NIH Device Record Key: 16c7591d-5e27-48a3-bb18-1402b37dc0e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response Navigation
• Version Model Number: 01-1800-6043
• Catalog Number: 01-1800-6043
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	00840194462785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203573

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

[00840194462785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [Response Navigation]

• 00841132184646: Navigation Instrument Case – Tray 2
• 00841132184639: Navigation Instrument Case – Tray 1
• 00841132181171: 4.5/5.0 Reduction Pedicle Screw Driver, Navigation
• 00841132181164: 4.5/5.0 Pedicle Screw Driver, Navigation
• 00841132181157: 5.5/6.0 Reduction Pedicle Screw Driver, Navigation
• 00841132181140: 5.5/6.0 Pedicle Screw Driver, Navigation
• 00841132181133: Lenke Probe, Curved, Navigation
• 00841132181126: Lenke Probe, Straight, Navigation
• 00841132181119: 6.0mm Tap, Single Lead, Navigation
• 00841132181102: 5.5mm Tap, Single Lead, Navigation
• 00841132181096: 5.0mm Tap, Single Lead, Navigation
• 00841132181089: 4.5mm Tap, Single Lead, Navigation
• 00841132181072: 4.0mm Tap, Single Lead, Navigation
• 00841132181065: 3.5mm Tap, Single Lead, Navigation
• 00841132181058: 3.0mm Tap, Single Lead, Navigation
• 00841132181041: 8.0mm Tap, Cannulated, Navigation
• 00841132181034: 7.0mm Tap, Cannulated, Navigation
• 00841132181027: 6.0mm Tap, Cannulated, Navigation
• 00841132181010: 5.5mm Tap, Cannulated, Navigation
• 00840194462785: 5.5/6.0 Cannulated Reduction Pedicle Screw Driver Navigation
• 00840194462778: 5.5/6.0 Cannulated Pedicle Screw Driver Navigation