Response 4.5/5.0 00-1600-2890

GUDID 00841132187180

4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 90MM - DOUBLE LEAD

ORTHOPEDIATRICS CORP.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00841132187180
• NIH Device Record Key: 112fc601-fa2c-4e49-8a8b-bf199fdfa3a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 4.5/5.0
• Version Model Number: 00-1600-2890
• Catalog Number: 00-1600-2890
• 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
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132187180 [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

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

[00841132187180]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

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
• 00841132187227: 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 100MM - DOUBLE LEAD
• 00841132187210: 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 90MM - DOUBLE LEAD
• 00841132187203: 4.5/5.0 POLYAXIAL PEDICLE SCREW 9MM X 80MM - DOUBLE LEAD
• 00841132187197: 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 100MM - DOUBLE LEAD
• 00841132187180: 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 90MM - DOUBLE LEAD
• 00841132187173: 4.5/5.0 POLYAXIAL PEDICLE SCREW 8MM X 80MM - DOUBLE LEAD
• 00840194418454: SI Fixation Lid
• 00840194418447: 4.5/5.0 SI Fixation Implant Caddy
• 00840194418300: 4.5/5.0 SI Fixation Caddy