Response Navigation 01-1800-3050

GUDID 00841132181096

5.0mm Tap, Single Lead, Navigation

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132181096
• NIH Device Record Key: 24cc565d-f273-40e4-8c15-4baee7f0591d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response Navigation
• Version Model Number: 01-1800-3050
• Catalog Number: 01-1800-3050
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132181096 [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

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

[00841132181096]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-04
• Device Publish Date: 2021-02-24

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