RESPONSE 5.5/6.0 SYSTEM

GUDID 00841132184615

S-ROD (HL), Ø 6.0MM TI ALLOY, 500MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132184615
• NIH Device Record Key: 4acf7909-93ea-442b-8ece-299d19e8919e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPONSE 5.5/6.0 SYSTEM
• Version Model Number: 00-1600-0115
• 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
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132184615 [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

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

[00841132184615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09

On-Brand Devices [RESPONSE 5.5/6.0 SYSTEM]

• 00841132184615: S-ROD (HL), Ø 6.0MM TI ALLOY, 500MM
• 00841132178874: 5.5/6.0 Closed Screw Cap Right
• 00841132178850: 5.5/6.0 Closed Screw Cap Left
• 00841132140321: S-ROD (HL), Ø 5.5MM TI ALLOY, 500MM
• 00841132140291: S-ROD (HL), Ø 6.0MM TI ALLOY, 400MM
• 00841132140284: S-ROD (HL), Ø 5.5MM TI ALLOY, 400MM
• 00841132140253: S-ROD, Ø 6.0MM TI ALLOY, 500MM, 80MM STRAIGHT
• 00841132140246: S-ROD, Ø 6.0MM TI ALLOY, 500MM, 65MM STRAIGHT
• 00841132140239: S-ROD, Ø 6.0MM TI ALLOY, 500MM, 50MM STRAIGHT
• 00841132140222: S-ROD, Ø 5.5MM TI ALLOY, 500MM, 80MM STRAIGHT
• 00841132140215: S-ROD, Ø 5.5MM TI ALLOY, 500MM, 65MM STRAIGHT
• 00841132140208: S-ROD, Ø 5.5MM TI ALLOY, 500MM, 50MM STRAIGHT
• 00841132140055: S-ROD, Ø 6.0MM TI ALLOY, 450MM, 80MM STRAIGHT
• 00841132140048: S-ROD, Ø 6.0MM TI ALLOY, 450MM, 65MM STRAIGHT
• 00841132140031: S-ROD, Ø 6.0MM TI ALLOY, 450MM, 50MM STRAIGHT
• 00841132140024: S-ROD, Ø 5.5MM TI ALLOY, 450MM, 80MM STRAIGHT
• 00841132140017: S-ROD, Ø 5.5MM TI ALLOY, 450MM, 65MM STRAIGHT
• 00841132140000: S-ROD, Ø 5.5MM TI ALLOY, 450MM, 50MM STRAIGHT
• 00841132139998: S-ROD, Ø 6.0MM TI ALLOY, 400MM, 80MM STRAIGHT
• 00841132139981: S-ROD, Ø 6.0MM TI ALLOY, 400MM, 65MM STRAIGHT
• 00841132139974: S-ROD, Ø 6.0MM TI ALLOY, 400MM, 50MM STRAIGHT
• 00841132139967: S-ROD, Ø 5.5MM TI ALLOY, 400MM, 80MM STRAIGHT
• 00841132139950: S-ROD, Ø 5.5MM TI ALLOY, 400MM, 65MM STRAIGHT
• 00841132139943: S-ROD, Ø 5.5MM TI ALLOY, 400MM, 50MM STRAIGHT
• 00840194416597: Response 5.5/6.0 1-Piece Rocker