ISOLA 50001538

GUDID 10705034011400

ISOLA SPINE SYSTEM EASY ROD 6.35 x 457.2mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10705034011400
NIH Device Record Keybfca2f49-7b79-4e3d-88de-0db52c01fb29
Commercial Distribution Discontinuation2019-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOLA
Version Model Number50001538
Catalog Number50001538
Company DUNS107105876
Company NameDEPUY SPINE, LLC
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)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034011400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034011400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-12
Device Publish Date2015-09-24

On-Brand Devices [ISOLA]

10705034243191ISOLA SPINE SYSTEM OFFSET SLOTTED CONNECTOR 6.35mm
10705034243184ISOLA SPINE SYSTEM ANGLED SLOTTED CONNECTOR 6.35mm
10705034003627ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm
10705034003405ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 6.35mm
10705034003399ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm
10705034001630ISOLA SPINE SYSTEM HOOK ROTATOR
10705034001524ISOLA SPINE SYSTEM OPEN HOOK CAP REMOVER
10705034011295ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm
10705034005782ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 9.5mm
10705034005737ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 8.0mm
10705034156460ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 5.5mm
10705034012940ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm
10705034012919ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm
10705034011400ISOLA SPINE SYSTEM EASY ROD 6.35 x 457.2mm
10705034011394ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm
10705034011370ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 609.6mm
10705034005126ISOLA SPINE SYSTEM MCC J-HOOK 6.35mm
10705034005119ISOLA SPINE SYSTEM MCC PLATE 50-70mm
10705034005096ISOLA SPINE SYSTEM MCC PLATE 30-50mm
10705034005072ISOLA SPINE SYSTEM MCC PLATE 15-30mm
10705034005065ISOLA SPINE SYSTEM MCC PLATE 10-25mm
10705034001456ISOLA SYSTEM MINI HEXDRIVER 3.18mm
10705034001340ISOLA SPINE SYSTEM GONIOMETER
10705034240718ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 4.75mm
10705034004853ISOLA SPINE SYSTEM BONE MARKER-DOUBLE BARREL
10705034004846ISOLA SPINE SYSTEM BONE MARKER-SINGLE BARREL
10705034001722ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER
10705034001715ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER
10705034001685ISOLA SPINE SYSTEM RING HANDLE ROD HOLDER 4.75mm
10705034001548ISOLA SPINE SYSTEM OPEN HOOK HOLDER
10705034001425ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 6.35mm
10705034001395ISOLA SPINE SYSTEM SMALL STRAIGHT ROD HOLDER 4.75mm
10705034001371ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 4.75mm
10705034001364ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 6.35mm
10705034001319ISOLA SPINE SYSTEM ROD HOLDER 6.35mm
10705034001302ISOLA SPINE SYSTEM ROD HOLDER 4.75mm
10705034184838ISOLA SPINE SYSTEM HOOK CASE
10705034184821ISOLA SPINE SYSTEM LOW BACK AUXILLARY TRAY
10705034004891ISOLA SPINE SYSTEM IMPLANT/INSTRUMENT CASE
10705034001203ISOLA SPINE SYSTEM OPEN CAP MANIPULATOR 4.75mm
10705034001180ISOLA SPINE SYSTEM HOOK COMPRESSOR
10705034001173ISOLA SPINE SYSTEM COMPRESSOR
10705034296128ISOLA SPINE SYSTEM AWL 90 DEGREES
10705034001555ISOLA SPINE SYSTEM SPINAL AWL
10705034241524ISOLA SPINE SYSTEM SET SCREW 3.17mm
10705034184845ISOLA SPINE SYSTEM TAP 10mm 40-120mm Plus or Minus 1.00 Percent
10705034001616ISOLA SPINE SYSTEM BONE SCREW TAP 8.5mm 40-70mm Plus or Minus 1.00 Percent
10705034001609ISOLA SPINE SYSTEM BONE SCREW TAP 7.75mm 40-70mm Plus or Minus 1.00 Percent
10705034001593ISOLA SPINE SYSTEM BONE SCREW TAP 7mm 40-70mm Plus or Minus 1.00 Percent
10705034001586ISOLA SPINE SYSTEM BONE SCREW TAP 6.25mm 40-70mm Plus or Minus 1.00 Percent

Trademark Results [ISOLA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOLA
ISOLA
88676041 not registered Live/Pending
Brindco International Beers Pvt Ltd
2019-10-31
ISOLA
ISOLA
88142586 not registered Dead/Abandoned
Isola Foods LLC
2018-10-04
ISOLA
ISOLA
87834525 not registered Dead/Abandoned
Isola & Co
2018-03-14
ISOLA
ISOLA
87524062 5473596 Live/Registered
AMT Group Bahamas Limited
2017-07-11
ISOLA
ISOLA
87144151 5344036 Live/Registered
Mia Cole, LLC
2016-08-19
ISOLA
ISOLA
85686746 4409690 Live/Registered
Isola USA Corp.
2012-07-25
ISOLA
ISOLA
85686504 4409689 Live/Registered
Isola USA Corp.
2012-07-25
ISOLA
ISOLA
85355297 not registered Dead/Abandoned
Marchesa Holdings, LLC
2011-06-24
ISOLA
ISOLA
85355278 not registered Dead/Abandoned
Marchesa Holdings, LLC
2011-06-24
ISOLA
ISOLA
85355267 not registered Dead/Abandoned
Marchesa Holdings, LLC
2011-06-24
ISOLA
ISOLA
79151222 not registered Dead/Abandoned
Isola Swim Pty Limited
2014-06-04
ISOLA
ISOLA
77811931 4339009 Live/Registered
Columbia Insurance Company
2009-08-25

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