Response Spine 5.5/6.0 System 00-1300-0750

GUDID 00841132100486

5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM

ORTHOPEDIATRICS CORP.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00841132100486
NIH Device Record Key46ea24e4-572b-4dd9-b9f3-230f3aaf5ebb
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse Spine 5.5/6.0 System
Version Model Number00-1300-0750
Catalog Number00-1300-0750
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 Datetrue
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
GS100841132100486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

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 Date2015-06-30

On-Brand Devices [Response Spine 5.5/6.0 System]

00841132131732Half Size Poly Reduction Pedicle Screw Case
00841132131725Half Size Poly Pedicle Screw Case
00841132131718Half Size Uni Reduction Pedicle Screw Case
00841132131701Half Size Uni Pedicle Screw Case
008411321316955.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 85mm Length
008411321316885.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 80mm Length
008411321316715.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 75mm Length
008411321316645.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 70mm Length
008411321316575.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 65mm Length
008411321316405.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 60mm Length
008411321316335.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 55mm Length
008411321316265.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 50mm Length
008411321316195.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 45mm Length
008411321316025.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 40mm Length
008411321315965.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 35mm Length
008411321315895.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 30mm Length
008411321315725.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 25mm Length
008411321315655.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 20mm Length
008411321315585.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 75mm Length
008411321315415.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 70mm Length
008411321315345.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 65mm Length
008411321315275.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 60mm Length
008411321315105.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 55mm Length
008411321315035.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 50mm Length
008411321314975.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 45mm Length
008411321314805.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 40mm Length
008411321314735.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 35mm Length
008411321314665.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 30mm Length
008411321314595.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 25mm Length
008411321314425.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 20mm Length
008411321314355.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 40mm Length
008411321314285.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 35mm Length
008411321314115.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 30mm Length
008411321314045.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 25mm Length
008411321313985.5/6.0 Polyaxial Reduction Pedicle Screws - Ø4.5mm, 20mm Length
008411321313815.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 85mm Length
008411321313745.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 80mm Length
008411321313675.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 75mm Length
008411321313505.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 70mm Length
008411321313435.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 65mm Length
008411321313365.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 60mm Length
008411321313295.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 55mm Length
008411321313125.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 50mm Length
008411321313055.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 45mm Length
008411321312995.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 40mm Length
008411321312825.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 35mm Length
008411321312755.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 30mm Length
008411321312685.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 35mm Length
008411321312515.5/6.0 Polyaxial Pedicle Screws - Ø6.5mm, 20mm Length
008411321312445.5/6.0 Polyaxial Pedicle Screws - Ø5.5mm, 75mm Length

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