Response 4.5/5.0 Spine System 00-1600-3262

GUDID 00841132153017

4.5/5.0 OPEN THORACIC HOOK, 10MM, NARROW

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00841132153017
NIH Device Record Key5372aa91-fa6d-4bf1-b593-c7cc94fd0ee0
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 4.5/5.0 Spine System
Version Model Number00-1600-3262
Catalog Number00-1600-3262
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132153017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132153017]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-13
Device Publish Date2020-03-05

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

008411321733674.5/5.0 Hook & Connector - Caddy
008411321733504.5/5.0 Pedicle Prep and Final Drive - Tray 3
00841132173343Transition Case - Tray 2
008411321733364.5/5.0 Hook & Connector - Tray 2
00841132173329Derotation Tray 1
008411321733124.5/5.0 Correction Tray 1
008411321733054.5/5.0 Rod and Rod Reduction - Tray 2
008411321732994.5/5.0 Polyaxial Reduction Screws - Caddy 2
008411321732824.5/5.0 Polyaxial Screws - Caddy 2
008411321732754.5/5.0 Pedicle Prep and Final Drive - Tray 2
00841132173268Transition Case - Tray 1
008411321732514.5/5.0 Hook & Connector - Tray 1
00841132173244Derotation Tray 2
008411321732374.5/5.0 Correction Tray 2
008411321732204.5/5.0 Rod and Rod Reduction - Tray 1
008411321732134.5/5.0 Uniaxial Reduction Screws - Caddy 1
008411321732064.5/5.0 Uniaxial Screws - Caddy 1
008411321731904.5/5.0 Pedicle Prep and Final Drive - Tray 1
008411321731834.5/5.0 Large Set Screw Caddy
008411321731764.5/5.0 Case Base
00841132156995T15 DRIVER
00841132156988LARGE SET SCREW DRIVER
00841132156971LARGE SET SCREW DRIVER, FINAL
008411321569644.5/5.0 Tower
00841132156957Flat Rod Bender, Right
00841132156940Flat Rod Bender, Left
00841132156933X-LINK SELECTOR (CALIPER)
00841132156926HOOK HOLDER, CURVED STR.
00841132156919HOOK HOLDER, CURVED LAT.
00841132156902ROD WRENCH
00841132156896HEAD POSITIONER
00841132156889BONE PLANAR
00841132156872REDUCTION PEDICLE SCREW DRIVER, HUDSON
00841132156865PEDICLE SCREW DRIVER, HUDSON
00841132156858HOOK PUSHER, C-SHAPED
00841132156841HOOK PUSHER, HOOK MATING
00841132156834HOOK HOLDER, STRAIGHT
00841132156827COUNTER TORQUE TUBE
00841132156810REDUCTION PEDICLE SCREW DRIVER, Power
00841132156803PEDICLE SCREW DRIVER, Power
00841132156797DISTRACTOR
00841132156780COMPRESSOR, SMALL
00841132156773ROCKER
00841132156766REDUCTION PEDICLE SCREW DRIVER
00841132156759PEDICLE SCREW DRIVER
00841132156742TAB BREAKER
00841132156735Mini Rod Reducer
008411321567284.5/5.0 Lid
00841132156711Rod Cutter Case
008411321567044.5/5.0 Unique Instruments

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