OP Response Spine System 00-1003-3103

GUDID 00841132120040

CLOSED PEDICLE HOOK, 9.5MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132120040
• NIH Device Record Key: 0c302ac9-e1d8-4b79-8c89-a48c2f1adf98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OP Response Spine System
• Version Model Number: 00-1003-3103
• Catalog Number: 00-1003-3103
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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: 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: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132120040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130655

FDA Product Code

• OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

On-Brand Devices [OP Response Spine System]

• 00841132122105: Ø5.5MM TI ALLOY ROD, 500MM
• 00841132122099: Ø5.5MM COCR ROD, 600MM
• 00841132122082: FIXED ANGLE SCREW 7.0MM X 80MM
• 00841132122075: FIXED ANGLE SCREW 7.0MM X 75MM
• 00841132122068: FIXED ANGLE SCREW 7.0MM X 70MM
• 00841132122051: FIXED ANGLE SCREW 7.0MM X 65MM
• 00841132122044: FIXED ANGLE SCREW 7.0MM X 60MM
• 00841132122037: FIXED ANGLE SCREW 7.0MM X 55MM
• 00841132122020: FIXED ANGLE SCREW 7.0MM X 50MM
• 00841132122013: FIXED ANGLE SCREW 7.0MM X 45MM
• 00841132122006: FIXED ANGLE SCREW 7.0MM X 40MM
• 00841132121993: FIXED ANGLE SCREW 7.0MM X 35MM
• 00841132121986: FIXED ANGLE SCREW 6.0MM X 70MM
• 00841132121979: FIXED ANGLE SCREW 6.0MM X 65MM
• 00841132121962: FIXED ANGLE SCREW 6.0MM X 60MM
• 00841132121955: FIXED ANGLE SCREW 6.0MM X 55MM
• 00841132121948: FIXED ANGLE SCREW 6.0MM X 50MM
• 00841132121931: FIXED ANGLE SCREW 6.0MM X 45MM
• 00841132121924: FIXED ANGLE SCREW 6.0MM X 40MM
• 00841132121917: FIXED ANGLE SCREW 6.0MM X 35MM
• 00841132121900: FIXED ANGLE SCREW 6.0MM X 30MM
• 00841132121894: FIXED ANGLE SCREW 5.0MM X 60MM
• 00841132121887: FIXED ANGLE SCREW 5.0MM X 55MM
• 00841132121870: FIXED ANGLE SCREW 5.0MM X 50MM
• 00841132121863: FIXED ANGLE SCREW 5.0MM X 45MM
• 00841132121856: FIXED ANGLE SCREW 5.0MM X 40MM
• 00841132121849: FIXED ANGLE SCREW 5.0MM X 35MM
• 00841132121832: FIXED ANGLE SCREW 5.0MM X 30MM
• 00841132121825: FIXED ANGLE SCREW 5.0MM X 25MM
• 00841132121818: FIXED ANGLE SCREW 5.0MM X 20MM
• 00841132121801: FIXED ANGLE SCREW 4.0MM X 40MM
• 00841132121795: FIXED ANGLE SCREW 4.0MM X 35MM
• 00841132121788: FIXED ANGLE SCREW 4.0MM X 30MM
• 00841132121771: FIXED ANGLE SCREW 4.0MM X 25MM
• 00841132121764: FIXED ANGLE SCREW 4.0MM X 20MM
• 00841132121757: REDUCTION UNIAXIAL SCREW 7.0MM X 80MM
• 00841132121740: REDUCTION UNIAXIAL SCREW 7.0MM X 75MM
• 00841132121733: REDUCTION UNIAXIAL SCREW 7.0MM X 70MM
• 00841132121726: REDUCTION UNIAXIAL SCREW 7.0MM X 65MM
• 00841132121719: REDUCTION UNIAXIAL SCREW 7.0MM X 60MM
• 00841132121702: REDUCTION UNIAXIAL SCREW 7.0MM X 55MM
• 00841132121696: REDUCTION UNIAXIAL SCREW 7.0MM X 50MM
• 00841132121689: REDUCTION UNIAXIAL SCREW 7.0MM X 45MM
• 00841132121672: REDUCTION UNIAXIAL SCREW 7.0MM X 40MM
• 00841132121665: REDUCTION UNIAXIAL SCREW 7.0MM X 35MM
• 00841132121658: REDUCTION UNIAXIAL SCREW 6.0MM X 70MM
• 00841132121641: REDUCTION UNIAXIAL SCREW 6.0MM X 65MM
• 00841132121634: REDUCTION UNIAXIAL SCREW 6.0MM X 60MM
• 00841132121627: REDUCTION UNIAXIAL SCREW 6.0MM X 55MM
• 00841132121610: REDUCTION UNIAXIAL SCREW 6.0MM X 50MM