Response 4.5/5.0 Spine System 00-1600-2620

GUDID 00841132152195

4.5/5.0 POLYAXIAL PEDICLE SCREW DL 6.0MM X 20MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00841132152195
• NIH Device Record Key: 8949496b-9193-47bd-bae7-83dbb21aa594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response 4.5/5.0 Spine System
• Version Model Number: 00-1600-2620
• Catalog Number: 00-1600-2620
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• 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: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132152195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181390

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00841132152195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-13
• Device Publish Date: 2020-03-05

On-Brand Devices [Response 4.5/5.0 Spine System]

• 00841132173367: 4.5/5.0 Hook & Connector - Caddy
• 00841132173350: 4.5/5.0 Pedicle Prep and Final Drive - Tray 3
• 00841132173343: Transition Case - Tray 2
• 00841132173336: 4.5/5.0 Hook & Connector - Tray 2
• 00841132173329: Derotation Tray 1
• 00841132173312: 4.5/5.0 Correction Tray 1
• 00841132173305: 4.5/5.0 Rod and Rod Reduction - Tray 2
• 00841132173299: 4.5/5.0 Polyaxial Reduction Screws - Caddy 2
• 00841132173282: 4.5/5.0 Polyaxial Screws - Caddy 2
• 00841132173275: 4.5/5.0 Pedicle Prep and Final Drive - Tray 2
• 00841132173268: Transition Case - Tray 1
• 00841132173251: 4.5/5.0 Hook & Connector - Tray 1
• 00841132173244: Derotation Tray 2
• 00841132173237: 4.5/5.0 Correction Tray 2
• 00841132173220: 4.5/5.0 Rod and Rod Reduction - Tray 1
• 00841132173213: 4.5/5.0 Uniaxial Reduction Screws - Caddy 1
• 00841132173206: 4.5/5.0 Uniaxial Screws - Caddy 1
• 00841132173190: 4.5/5.0 Pedicle Prep and Final Drive - Tray 1
• 00841132173183: 4.5/5.0 Large Set Screw Caddy
• 00841132173176: 4.5/5.0 Case Base
• 00841132156995: T15 DRIVER
• 00841132156988: LARGE SET SCREW DRIVER
• 00841132156971: LARGE SET SCREW DRIVER, FINAL
• 00841132156964: 4.5/5.0 Tower
• 00841132156957: Flat Rod Bender, Right
• 00841132156940: Flat Rod Bender, Left
• 00841132156933: X-LINK SELECTOR (CALIPER)
• 00841132156926: HOOK HOLDER, CURVED STR.
• 00841132156919: HOOK HOLDER, CURVED LAT.
• 00841132156902: ROD WRENCH
• 00841132156896: HEAD POSITIONER
• 00841132156889: BONE PLANAR
• 00841132156872: REDUCTION PEDICLE SCREW DRIVER, HUDSON
• 00841132156865: PEDICLE SCREW DRIVER, HUDSON
• 00841132156858: HOOK PUSHER, C-SHAPED
• 00841132156841: HOOK PUSHER, HOOK MATING
• 00841132156834: HOOK HOLDER, STRAIGHT
• 00841132156827: COUNTER TORQUE TUBE
• 00841132156810: REDUCTION PEDICLE SCREW DRIVER, Power
• 00841132156803: PEDICLE SCREW DRIVER, Power
• 00841132156797: DISTRACTOR
• 00841132156780: COMPRESSOR, SMALL
• 00841132156773: ROCKER
• 00841132156766: REDUCTION PEDICLE SCREW DRIVER
• 00841132156759: PEDICLE SCREW DRIVER
• 00841132156742: TAB BREAKER
• 00841132156735: Mini Rod Reducer
• 00841132156728: 4.5/5.0 Lid
• 00841132156711: Rod Cutter Case
• 00841132156704: 4.5/5.0 Unique Instruments