Response 5.5/6.0 00-1750-3181

GUDID 00840194405270

5.5/6.0 closed lateral connector, 80mm

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00840194405270
NIH Device Record Key51f293d4-458a-47f8-9185-dde2a34ffc6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5/6.0
Version Model Number00-1750-3181
Catalog Number00-1750-3181
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
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194405270 [Primary]

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


[00840194405270]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

On-Brand Devices [Response 5.5/6.0]

008411321911495.5/6.0 Open/ Open domino connector
008411321911325.5/6.0 Open/ Closed wedding band
008411321911255.5/6.0 Open/ Open wedding band connector, 20mm
008411321911185.5/6.0 Open/ Open wedding band connector, 15mm
008411321911015.5/6.0 Open/ Open wedding band connector, 10mm
008411321910955.5/6.0 double open lateral connector, 80mm
008411321910885.5/6.0 double open lateral connector, 60mm
008411321910715.5/6.0 double open lateral connector, 40mm
008411321910645.5/6.0 closed lateral connector, 60mm
008411321910575.5/6.0 closed lateral connector, 40mm
008411321910405.5/6.0 closed lateral connector, 20mm
008411321910335.5/6.0 closed stopper
008411321789115.5/6.0 Elevated polyaxial lateral connector, 40mm
008411321788985.5/6.0 Elevated polyaxial lateral connector, 20mm
008401944052875.5/6.0 2 screw open lateral, 20mm
008401944052705.5/6.0 closed lateral connector, 80mm

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