PIVOX™ Oblique Lateral Spinal System

GUDID 00643169605121

SPACER 2131560 OLIF25 27MM 6 DEG 16X60

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage
Primary Device ID00643169605121
NIH Device Record Key74f4348f-bc43-43e8-86a4-22a55a7a911e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIVOX™ Oblique Lateral Spinal System
Version Model Number2131560
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 Latextrue
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

Width27 Millimeter
Width27 Millimeter
Width27 Millimeter
Width27 Millimeter
Width27 Millimeter
Width27 Millimeter
Width27 Millimeter
Width27 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169605121 [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 Date2020-02-24
Device Publish Date2016-01-20

On-Brand Devices [PIVOX™ Oblique Lateral Spinal System]

00643169654723SCREW 2140150 LUMBAR BONE 5.5 X 50MM
00643169654716SCREW 2140145 LUMBAR BONE 5.5 X 45MM
00643169649620TRAY 2201005 PIVOX 27MM TRIALS
00643169639621INSERTER 2163000 OLIF25 IB TRIAL INSERTR
00643169639614REMOVER 2162000 OLIF25 INTERBODY REMOVER
00643169639607SHAFT 2161001 OLIF25 INTERBODY THREADED
00643169639591INSERTER 2161000 OLIF25 INTERBODY
00643169639584TRIAL 2143002 OLIF25 PLATE TRIAL LARGE
00643169639577TRIAL 2143001 OLIF25 PLATE TRIAL SMALL
00643169639560INSERTER 2141000 OLIF25 PLATE
00643169639553SHAFT 2140020 OLIF25 PLATE-CAGE CENTER
00643169639546GUIDE 2140012 LRGE PLATE SCREW INSERTION
00643169639539GUIDE 2140011 SMLL PLATE SCREW INSERTION
00643169639522INSERTER 2140010 OLIF25 PLATE-CAGE
00643169637528TRAY 2201004 PIVOX 20MM 12-18 DEG TRIALS
00643169634787SCREW 2140140 LUMBAR BONE 5.5 X 40MM
00643169634770SCREW 2140135 LUMBAR BONE 5.5 X 35MM
00643169634763SCREW 2140130 LUMBAR BONE 5.5 X 30MM
00643169634756SCREW 2140125 LUMBAR BONE 5.5 X 25MM
00643169634749SCREW 2140120 LUMBAR BONE 5.5 X 20MM
00643169631533TRAY 2201002 PIVOX 20MM 6 DEGREE TRIALS
00643169631526TRAY 2201001 PIVOX INSTRUMENT SET 2
00643169631519TRAY 2201000 PIVOX INSTRUMENT SET 1
00643169606715SPACER 2123660 O25 23.5MM 18 DEG 18X60
00643169606708SPACER 2123655 O25 23.5MM 18 DEG 18X55
00643169606692SPACER 2123650 O25 23.5MM 18 DEG 18X50
00643169606685SPACER 2123645 O25 23.5MM 18 DEG 18X45
00643169606678SPACER 2123640 O25 23.5MM 18 DEG 18X40
00643169606661SPACER 2123560 O25 23.5MM 18 DEG 16X60
00643169606654SPACER 2123555 O25 23.5MM 18 DEG 16X55
00643169606647SPACER 2123550 O25 23.5MM 18 DEG 16X50
00643169606630SPACER 2123545 O25 23.5MM 18 DEG 16X45
00643169606623SPACER 2123540 O25 23.5MM 18 DEG 16X40
00643169606616SPACER 2123460 O25 23.5MM 18 DEG 14X60
00643169606609SPACER 2123455 O25 23.5MM 18 DEG 14X55
00643169606593SPACER 2123450 O25 23.5MM 18 DEG 14X50
00643169606586SPACER 2123445 O25 23.5MM 18 DEG 14X45
00643169606579SPACER 2123440 O25 23.5MM 18 DEG 14X40
00643169606517SPACER 2122660 O25 23.5MM 12 DEG 18X60
00643169606500SPACER 2122655 O25 23.5MM 12 DEG 18X55
00643169606494SPACER 2122650 O25 23.5MM 12 DEG 18X50
00643169606487SPACER 2122645 O25 23.5MM 12 DEG 18X45
00643169606470SPACER 2122640 O25 23.5MM 12 DEG 18X40
00643169606463SPACER 2122560 O25 23.5MM 12 DEG 16X60
00643169606456SPACER 2122555 O25 23.5MM 12 DEG 16X55
00643169606449SPACER 2122550 O25 23.5MM 12 DEG 16X50
00643169606432SPACER 2122545 O25 23.5MM 12 DEG 16X45
00643169606425SPACER 2122540 O25 23.5MM 12 DEG 16X40
00643169606418SPACER 2122460 O25 23.5MM 12 DEG 14X60
00643169606401SPACER 2122455 O25 23.5MM 12 DEG 14X55

Trademark Results [PIVOX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PIVOX
PIVOX
86598634 5087447 Live/Registered
Warsaw Orthopedic, Inc.
2015-04-15

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