ATLANTIS ESSENTIALS™ Anterior Cervical Plate System

GUDID 00643169587199

SCREW G73733041012 4.0X12 SLF-TAP FIX 1P

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID00643169587199
NIH Device Record Keybedd8aa8-a0be-4595-befe-668d419644e2
Commercial Distribution Discontinuation2019-05-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameATLANTIS ESSENTIALS™ Anterior Cervical Plate System
Version Model NumberG73733041012
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
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 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(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169587199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-27
Device Publish Date2016-01-15

On-Brand Devices [ATLANTIS ESSENTIALS™ Anterior Cervical Plate System]

00643169619166PLATE G7371357 SDS 57.5MM TI STERILE
00643169619159PLATE G7371352 SDS 52.5MM TI STERILE
00643169619142PLATE G7371350 SDS 50MM TI STERILE
00643169619135PLATE G7371347 SDS 47.5MM TI STERILE
00643169619128PLATE G7371332 SDS 32.5MM TI STERILE
00643169619111PLATE G7371330 SDS 30MM TI STERILE
00643169589810TEMPLATE 7372542 42.5MM PLATE TEMPLATE
00643169588004SCREW G73733031517 4.5X17 SLF-DRL FIX 1P
00643169587991SCREW G73733031515 4.5X15 SLF-DRL FIX 1P
00643169587984SCREW G73733031513 4.5X13 SLF-DRL FIX 1P
00643169587977SCREW G73733031511 4.5X11 SLF-DRL FIX 1P
00643169587854SCREW G73733031020 4.0X20 SLF-DRL FIX 1P
00643169587847SCREW G73733031019 4.0X19 SLF-DRL FIX 1P
00643169587830SCREW G73733031018 4.0X18 SLF-DRL FIX 1P
00643169587823SCREW G73733031017 4.0X17 SLF-DRL FIX 1P
00643169587816SCREW G73733031016 4.0X16 SLF-DRL FIX 1P
00643169587809SCREW G73733031015 4.0X15 SLF-DRL FIX 1P
00643169587793SCREW G73733031014 4.0X14 SLF-DRL FIX 1P
00643169587786SCREW G73733031013 4.0X13 SLF-DRL FIX 1P
00643169587779SCREW G73733031012 4.0X12 SLF-DRL FIX 1P
00643169587762SCREW G73733031011 4.0X11 SLF-DRL FIX 1P
00643169587755SCREW G73733031010 4.0X10 SLF-DRL FIX 1P
00643169587427SCREW G73733041517 4.5X17 SLF-TAP FIX 1P
00643169587410SCREW G73733041515 4.5X15 SLF-TAP FIX 1P
00643169587403SCREW G73733041513 4.5X13 SLF-TAP FIX 1P
00643169587397SCREW G73733041511 4.5X11 SLF-TAP FIX 1P
00643169587274SCREW G73733041020 4.0X20 SLF-TAP FIX 1P
00643169587267SCREW G73733041019 4.0X19 SLF-TAP FIX 1P
00643169587250SCREW G73733041018 4.0X18 SLF-TAP FIX 1P
00643169587243SCREW G73733041017 4.0X17 SLF-TAP FIX 1P
00643169587236SCREW G73733041016 4.0X16 SLF-TAP FIX 1P
00643169587229SCREW G73733041015 4.0X15 SLF-TAP FIX 1P
00643169587212SCREW G73733041014 4.0X14 SLF-TAP FIX 1P
00643169587205SCREW G73733041013 4.0X13 SLF-TAP FIX 1P
00643169587199SCREW G73733041012 4.0X12 SLF-TAP FIX 1P
00643169587182SCREW G73733041011 4.0X11 SLF-TAP FIX 1P
00643169587175SCREW G73733041010 4.0X10 SLF-TAP FIX 1P
00643169576018SCREW G73733131517 4.5X17 SLF-DRL VAR 1P
00643169576001SCREW G73733131515 4.5X15 SLF-DRL VAR 1P
00643169575998SCREW G73733131513 4.5X13 SLF-DRL VAR 1P
00643169575981SCREW G73733131511 4.5X11 SLF-DRL VAR 1P
00643169575868SCREW G73733131020 4.0X20 SLF-DRL VAR 1P
00643169575851SCREW G73733131019 4.0X19 SLF-DRL VAR 1P
00643169575844SCREW G73733131018 4.0X18 SLF-DRL VAR 1P
00643169575837SCREW G73733131017 4.0X17 SLF-DRL VAR 1P
00643169575820SCREW G73733131016 4.0X16 SLF-DRL VAR 1P
00643169575813SCREW G73733131015 4.0X15 SLF-DRL VAR 1P
00643169575806SCREW G73733131014 4.0X14 SLF-DRL VAR 1P
00643169575790SCREW G73733131013 4.0X13 SLF-DRL VAR 1P
00643169575783SCREW G73733131012 4.0X12 SLF-DRL VAR 1P

Trademark Results [ATLANTIS ESSENTIALS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ATLANTIS ESSENTIALS
ATLANTIS ESSENTIALS
86702189 5023923 Live/Registered
Warsaw Orthopedic, Inc.
2015-07-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.