Response 5.5/6.0 Spine 44-1300-0080

GUDID 00841132137345

RESPONSE 5.5/6.0 POLYAXIAL SCREW

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132137345
• NIH Device Record Key: b2306a15-8af1-4dd1-ada9-4d08fc492ac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 5.5/6.0 Spine
• Version Model Number: 44-1300-0080
• Catalog Number: 44-1300-0080
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: Rzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132137345 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-29

On-Brand Devices [Response 5.5/6.0 Spine]

• 00841132137420: RESPONSE 5.5/6.0 EXTRA LARGE-SIZE SCREW
• 00841132137413: RESPONSE 5.5/6.0 EXTRA LP ROD REDUCTION TOWER
• 00841132137406: RESPONSE 5.5/6.0 EXTRA UNIAXIAL AND POLYAXIAL SCREW
• 00841132137390: RESPONSE 5.5/6.0 EXTRA JIMINY
• 00841132137383: RESPONSE 5.5/6.0 ROD CUTTER
• 00841132137376: RESPONSE 5.5/6.0 FIXED ANGLE SCREW
• 00841132137369: RESPONSE 5.5/6.0 HOOK
• 00841132137352: RESPONSE 5.5/6.0 REDUCTION SCREW
• 00841132137345: RESPONSE 5.5/6.0 POLYAXIAL SCREW
• 00841132137338: RESPONSE 5.5/6.0 UNIAXIAL SCREW
• 00841132137321: RESPONSE 5.5/6.0 COUPLE DEROTATION
• 00841132137314: RESPONSE 5.5/6.0 TORQUE
• 00841132137307: RESPONSE 5.5/6.0 BENDER
• 00841132137291: RESPONSE 5.5/6.0 ROD REDUCTION
• 00841132137284: RESPONSE 5.5/6.0 PEDICLE PREP
• 00841132137277: RESPONSE 5.5/6.0 IMPLANTS & INSTRUMENTS
• 00841132145395: 5.5MM SOLID TAP, DOUBLE LEAD, POWER
• 00841132145388: 4.5MM SOLID TAP, DOUBLE LEAD, POWER
• 00841132145371: 3.5MM SOLID TAP, DOUBLE LEAD, POWER
• 00841132178508: Response 5.5/6.0 Polyaxial Reduction Screw Caddy
• 00841132178485: Response 5.5/6.0 Uniaxial Reduction Screw Caddy
• 00841132184677: NM Case- Tray 3
• 00841132184660: NM Case- Tray 2
• 00841132184622: NM Case- Caddy 1