Response 5.5/6.0 Spine System 00-1350-1845

GUDID 00841132175255

8mm x 45mm 5.5/6.0 UNIAXIAL REDUCTION SINGLE LEAD PEDICLE SCREW ASSEMBLY

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00841132175255
NIH Device Record Key77558a3f-4298-45bb-98ae-ef8ef9807ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse 5.5/6.0 Spine System
Version Model Number00-1350-1845
Catalog Number00-1350-1845
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
GS100841132175255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132175255]

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 5.5/6.0 Spine System]

00084113213712SET SCREW TORQUE LIMITER, GRAY T-HANDLE 13 N-m
008411321776795.5/6.0 - 40 DEG. OFFSET HOOK, Right 6.5mm
008411321776625.5/6.0 - 40 DEG. OFFSET HOOK, Left 6.5mm
008411321776555.5/6.0 - 40 DEG. OFFSET HOOK, Right 8mm
008411321776485.5/6.0 - 40 DEG. OFFSET HOOK, Left 8mm
008411321836945.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length
008411321836875.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length
008411321836705.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length
008411321836635.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length
008411321836565.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length
008411321836495.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length
008411321836325.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length
008411321836255.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length
008411321836185.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length
008411321836015.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length
008411321835955.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length
008411321835885.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length
008411321835715.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length
008411321835645.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length
008411321835575.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 75mm Length
008411321835405.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 70mm Length
008411321835335.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 65mm Length
008411321835265.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 60mm Length
008411321835195.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 55mm Length
008411321835025.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 50mm Length
008411321834965.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 45mm Length
008411321834895.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 40mm Length
008411321834725.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 35mm Length
008411321834655.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 30mm Length
008411321834585.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 25mm Length
008411321834415.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 5.5mm, 20mm Length
008411321834345.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 40mm Length
008411321834275.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 35mm Length
008411321834105.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 30mm Length
008411321834035.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 25mm Length
008411321833975.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 4.5mm, 20mm Length
008411321833805.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 85mm Length
008411321833735.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 80mm Length
008411321833665.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 75mm Length
008411321833595.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 70mm Length
008411321833425.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 65mm Length
008411321833355.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 60mm Length
008411321833285.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 55mm Length
008411321833115.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 50mm Length
008411321833045.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 45mm Length
008411321832985.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 40mm Length
008411321832815.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 35mm Length
008411321832745.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 30mm Length
008411321832675.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 25mm Length
008411321832505.5/6.0 Uniaxial Reduction Single Lead Pedicle Screw - DIA 6.5mm, 20mm Length

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