RESPONSE Spine 00-1003-4301

GUDID 00841132136423

COMPONENT PART, NOT SOLD UNDER THIS PART NUMBER

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132136423
• NIH Device Record Key: 8a0c77a0-f479-4d72-a8f7-b8669d3c5e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPONSE Spine
• Version Model Number: 00-1003-4301
• Catalog Number: 00-1003-4301
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132136423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160466

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: 2017-02-15

On-Brand Devices [RESPONSE Spine]

• 00841132136478: 5.5MM ROD, COCR, SINGLE HEX, 600MM LENGTH
• 00841132136461: 5.5MM ROD, COCR, SINGLE HEX, 500MM LENGTH
• 00841132136454: COMPONENT PART, NOT SOLD UNDER THIS PART NUMBER
• 00841132136447: COMPONENT PART, NOT SOLD UNDER THIS PART NUMBER
• 00841132136430: COMPONENT PART, NOT SOLD UNDER THIS PART NUMBER
• 00841132136423: COMPONENT PART, NOT SOLD UNDER THIS PART NUMBER
• 00841132135938: REDUCTION SCREW CASE
• 00841132135921: BASE ASSEMBLY
• 00841132135723: JIMINY DEROTATION HANDLE, LOCKING
• 00841132135716: JIMINY LID
• 00841132135198: REDUCTION SLEEVE
• 00841132133576: RESPONSE SPINE IMPLANTS REDUCTION SCREWS CASE
• 00841132133569: RESPONSE SPINE IMPLANTS FIXED ANGLED SCREW CASE
• 00841132133552: RESPONSE SPINE IMPLANTS HOOK CASE
• 00841132133545: RESPONSE SPINE IMPLANTS POLYAXIAL CASE
• 00841132133538: RESPONSE SPINE IMPLANTS UNIAXIAL CASE
• 00841132133521: RESPONSE SPINE COUPLED DEROTATION CASE 6
• 00841132133514: RESPONSE SPINE TORQUE CASE 5
• 00841132133507: RESPONSE SPINE BENDERS CASE 4
• 00841132133491: RESPONSE SPINE ROD REDUCTION CASE 3
• 00841132133484: RESPONSE SPINE PEDICLE PREP CASE 2
• 00841132133477: RESPONSE SPINE IMPLANT & INST CASE 1
• 00841132133460: RESPONSE SPINE SYSTEM
• 00841132128916: HOOK CASE
• 00841132128909: COUPLE DEROTATION CASE 6
• 00841132128893: TORQUE CASE 5
• 00841132128886: BENDER CASE 4
• 00841132128879: SPINE REDUCTION CASE 3 CASES AND TRAYS
• 00841132128862: PEDICLE PREPARATION CASE AND TRAYS
• 00841132128855: IMPLANT INSTRUMENT CASE 1
• 00841132128848: POLYAXIAL SCREW CASE AND TRAY
• 00841132128831: UNIAXIAL SCREW CASE AND TRAY
• 00841132128794: ORTHOPEDIATRICS LID
• 00841132128787: HOOK INSTRUMENT, ANGLED PEDICLE
• 00841132128770: HOOK INSTRUMENT, ANGLED LAMINAR WIDE BLADE
• 00841132128763: HOOK INSTRUMENT, ANGLED LAMINAR NARROW BLADE
• 00841132123942: 5.5MM ROD, COCR, SINGLE HEX, 600MM LENGTH
• 00841132123935: 5.5MM ROD, COCR, SINGLE HEX, 500MM LENGTH
• 00841132144176: CORONAL BENDER, LEFT