OP Response Spine System 00-1003-3089

GUDID 00841132119914

FIXED CROSS CONNECTOR, 20MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00841132119914
NIH Device Record Key9836fc10-1e33-4e92-8c3e-8126c247d19a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOP Response Spine System
Version Model Number00-1003-3089
Catalog Number00-1003-3089
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132119914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-09-08

On-Brand Devices [OP Response Spine System]

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

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