Response 5.5/6.0 00-1301-7111

GUDID 00841132187340

5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 110MM

ORTHOPEDIATRICS CORP.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00841132187340
• NIH Device Record Key: b55a2737-df5d-445a-ae7b-0466e24cdd9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 5.5/6.0
• Version Model Number: 00-1301-7111
• Catalog Number: 00-1301-7111
• 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	00841132187340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222105

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

Moist Heat or Steam Sterilization

[00841132187340]

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 5.5/6.0]

• 00841132191149: 5.5/6.0 Open/ Open domino connector
• 00841132191132: 5.5/6.0 Open/ Closed wedding band
• 00841132191125: 5.5/6.0 Open/ Open wedding band connector, 20mm
• 00841132191118: 5.5/6.0 Open/ Open wedding band connector, 15mm
• 00841132191101: 5.5/6.0 Open/ Open wedding band connector, 10mm
• 00841132191095: 5.5/6.0 double open lateral connector, 80mm
• 00841132191088: 5.5/6.0 double open lateral connector, 60mm
• 00841132191071: 5.5/6.0 double open lateral connector, 40mm
• 00841132191064: 5.5/6.0 closed lateral connector, 60mm
• 00841132191057: 5.5/6.0 closed lateral connector, 40mm
• 00841132191040: 5.5/6.0 closed lateral connector, 20mm
• 00841132191033: 5.5/6.0 closed stopper
• 00841132178911: 5.5/6.0 Elevated polyaxial lateral connector, 40mm
• 00841132178898: 5.5/6.0 Elevated polyaxial lateral connector, 20mm
• 00840194405287: 5.5/6.0 2 screw open lateral, 20mm
• 00840194405270: 5.5/6.0 closed lateral connector, 80mm
• 00841132187371: 9.5mm Cannulated Tap
• 00841132187364: 9mm Cannulated Tap
• 00841132187357: 8.5mm Cannulated Tap
• 00841132187340: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 110MM
• 00841132187333: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 100MM
• 00841132187326: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 90MM
• 00841132187319: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10.5MM X 80MM
• 00841132187302: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 110MM
• 00841132187296: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 100MM
• 00841132187289: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 90MM
• 00841132187272: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 10MM X 80MM
• 00841132187265: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 110MM
• 00841132187258: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 100MM
• 00841132187241: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 90MM
• 00841132187234: 5.5/6.0 CANNULATED POLYAXIAL PEDICLE SCREW 9.5MM X 80MM
• 00840194418461: 5.5/6.0 SI Fixation Implant Caddy
• 00840194418294: 5.5/6.0 SI Fixation Caddy
• 00840194418270: Tap 10.5mm, Cannulated, ZH Connect
• 00840194418263: Tap 10mm, Cannulated, ZH Connect