Response 4.5/5.0 00-1650-8851

GUDID 00841132185384

4.5/5.5 TRANSITION ROD, COCR, 600MM

ORTHOPEDIATRICS CORP.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00841132185384
• NIH Device Record Key: b381bbeb-ad4b-4c1c-91ea-c0e79e93d1cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 4.5/5.0
• Version Model Number: 00-1650-8851
• Catalog Number: 00-1650-8851
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132185384 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

[00841132185384]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-14
• Device Publish Date: 2025-02-06

On-Brand Devices [Response 4.5/5.0]

• 00841132187166: 5.0/5.5 TRANSITION ROD, TI ALLOY, 600MM
• 00841132185414: 5.0/6.0 TRANSITION ROD, COCR, 600MM
• 00841132185407: 5.0/5.5 TRANSITION ROD, COCR, 600MM
• 00841132185391: 4.5/6.0 TRANSITION ROD, COCR, 600MM
• 00841132185384: 4.5/5.5 TRANSITION ROD, COCR, 600MM
• 00841132185377: 5.0/6.0 TRANSITION ROD, TI ALLOY, 600MM