Response Navigation 01-1800-3040

GUDID 00841132181072

4.0mm Tap, Single Lead, Navigation

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132181072
NIH Device Record Key096409fa-fa27-4f6f-8577-2aeb631a156f
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponse Navigation
Version Model Number01-1800-3040
Catalog Number01-1800-3040
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132181072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

[00841132181072]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-04
Device Publish Date2021-02-24

On-Brand Devices [Response Navigation]

00841132184646Navigation Instrument Case – Tray 2
00841132184639Navigation Instrument Case – Tray 1
008411321811714.5/5.0 Reduction Pedicle Screw Driver, Navigation
008411321811644.5/5.0 Pedicle Screw Driver, Navigation
008411321811575.5/6.0 Reduction Pedicle Screw Driver, Navigation
008411321811405.5/6.0 Pedicle Screw Driver, Navigation
00841132181133Lenke Probe, Curved, Navigation
00841132181126Lenke Probe, Straight, Navigation
008411321811196.0mm Tap, Single Lead, Navigation
008411321811025.5mm Tap, Single Lead, Navigation
008411321810965.0mm Tap, Single Lead, Navigation
008411321810894.5mm Tap, Single Lead, Navigation
008411321810724.0mm Tap, Single Lead, Navigation
008411321810653.5mm Tap, Single Lead, Navigation
008411321810583.0mm Tap, Single Lead, Navigation
008411321810418.0mm Tap, Cannulated, Navigation
008411321810347.0mm Tap, Cannulated, Navigation
008411321810276.0mm Tap, Cannulated, Navigation
008411321810105.5mm Tap, Cannulated, Navigation
008401944627855.5/6.0 Cannulated Reduction Pedicle Screw Driver Navigation
008401944627785.5/6.0 Cannulated Pedicle Screw Driver Navigation
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.