PREMIER® Anterior Cervical Plate System

GUDID 00885074229294

PLATE 6861285 85MM FSP ANTERIOR CRV

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00885074229294
NIH Device Record Key4d92acfa-5b7c-4889-a1f7-32be9ad7a532
Commercial Distribution Discontinuation2018-10-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePREMIER® Anterior Cervical Plate System
Version Model Number6861285
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter
Width85 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074229294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


[00885074229294]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-31
Device Publish Date2015-08-19

On-Brand Devices [PREMIER® Anterior Cervical Plate System]

00613994557568PLATE X1108058 PRE PLT 32.5MM 2LEV
00613994234889PLATE X0206145 PRE FSP PLT 23MM 1LEV
00613994234872PLATE X0206147 PRE FSP PLT 27.5MM 1LEV
00613994234865PLATE X0206148 PRE FSP PLT 37.5MM 2LEV
00613994234858PLATE X0206149 PRE FSP PLT 40MM 2LEV
00613994234841PLATE X0206150 PRE FSP PLT 42.5MM 2LEV
00613994234834PLATE X0206151 PRE FSP PLT 45MM 2LEV
00681490519304CASE 1860503 PREMIER SCREW TRAY MODULE
00681490519281CASE 1860501 GENERIC BASE PREMIER
00681490482462PLATE 6860210 110 MM ANT CERV
00681490482455PLATE 6860205 105 MM ANT CERV
00681490482448PLATE 6860200 100 MM ANT CERV
00681490482431PLATE 6860195 95 MM ANT CERV
00681490482424PLATE 6860190 90 MM ANT CERV
00681490482417PLATE 6860187 87 5MM ANT CERV
00681490482400PLATE 6860185 85 MM ANT CERV
00681490482394PLATE 6860182 82 5MM ANT CERV
00681490482387PLATE 6860180 80 MM ANT CERV
00681490482370PLATE 6860177 77 5MM ANT CERV
00681490482363PLATE 6860175 75 MM ANT CERV
00681490482356PLATE 6860172 72.5MM ANTERIOR CERVICAL
00681490482349PLATE 6860170 70 MM ANTERIOR CERVICAL
00681490482332PLATE 6860167 67.5MM ANTERIOR CERVICAL
00681490482325PLATE 6860165 65 MM ANTERIOR CERVICAL
00681490482318PLATE 6860162 62.5MM ANTERIOR CERVICAL
00681490482301PLATE 6860160 60 MM ANTERIOR CERVICAL
00681490482295PLATE 6860157 57.5MM ANTERIOR CERVICAL
00681490482288PLATE 6860155 55 MM ANTERIOR CERVICAL
00681490482271PLATE 6860152 52.5MM ANTERIOR CERVICAL
00681490482264PLATE 6860150 50 MM ANTERIOR CERVICAL
00681490482257PLATE 6860147 47.5MM ANTERIOR CERVICAL
00681490482240PLATE 6860145 45 MM ANTERIOR CERVICAL
00681490482233PLATE 6860142 42.5MM ANTERIOR CERVICAL
00681490482226PLATE 6860140 40 MM ANTERIOR CERVICAL
00681490482219PLATE 6860137 37.5MM ANTERIOR CERVICAL
00681490482202PLATE 6860135 35 MM ANTERIOR CERVICAL
00681490482196PLATE 6860132 32.5MM ANTERIOR CERVICAL
00681490482189PLATE 6860130 30 MM ANTERIOR CERVICAL
00681490482172PLATE 6860127 27.5MM ANTERIOR CERVICAL
00681490482165PLATE 6860125 25 MM ANTERIOR CERVICAL
00681490482158PLATE 6860123 23 MM ANTERIOR CERVICAL
00681490482141BONE SCREW 6860057 SELF TAPPING 4.5X17MM
00681490482134BONE SCREW 6860055 SELF TAPPING 4.5X15MM
00681490482127SCREW 6860053 VA SELF TAPPING 4.5X13MM
00681490482110SCREW 6860020 VA SELF TAPPING 4.0X20MM
00681490482103SCREW 6860019 VA SELF TAPPING 4.0X19MM
00681490482097SCREW 6860018 VA SELF TAPPING 4.0X18MM
00681490482080SCREW 6860017 VA SELF TAPPING 4.0X17MM
00681490482073SCREW 6860016 VAST CNCLLS 4.0X16MM
00681490482066SCREW 6860015 VAST CNCLLS 4.0X15MM

Trademark Results [PREMIER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREMIER
PREMIER
98596437 not registered Live/Pending
A&D Building Supply Inc
2024-06-11
PREMIER
PREMIER
98294955 not registered Live/Pending
TECHNICAL CHEMICAL COMPANY
2023-12-01
PREMIER
PREMIER
98191669 not registered Live/Pending
C.R. England, Inc.
2023-09-21
PREMIER
PREMIER
98128845 not registered Live/Pending
Span.IO, Inc.
2023-08-11
PREMIER
PREMIER
97978040 not registered Live/Pending
Multivox Premier Guitar and Amplification LLC
2021-12-22
PREMIER
PREMIER
97917291 not registered Live/Pending
Seachem Laboratories, Inc.
2023-05-02
PREMIER
PREMIER
97523650 not registered Live/Pending
Tagi Store Ltd
2022-07-28
PREMIER
PREMIER
97296310 not registered Live/Pending
DNVB Inc.
2022-03-04
PREMIER
PREMIER
97184081 not registered Live/Pending
Multivox Premier Guitar and Amplification LLC
2021-12-22
PREMIER
PREMIER
90887562 not registered Live/Pending
Long Item Development
2021-08-17
PREMIER
PREMIER
90531040 not registered Live/Pending
DONGGUAN PREMIER HOME FURNISHING CO., LTD
2021-02-16
PREMIER
PREMIER
90462672 not registered Live/Pending
TPE Enterprises, LLC
2021-01-13

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