ISOLA 500001
GUDID 10705034003245
ISOLA SPINE SYSTEM PLATE/ROD COMBINATION 1
DEPUY SPINE, LLC
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 10705034003245 |
| NIH Device Record Key | 3821d3c1-16b9-49b6-bc27-8e988d10c604 |
| Commercial Distribution Discontinuation | 2018-06-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ISOLA |
| Version Model Number | 500001 |
| Catalog Number | 500001 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034003245 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980485
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
[10705034003245]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [ISOLA]
| 10705034243191 | ISOLA SPINE SYSTEM OFFSET SLOTTED CONNECTOR 6.35mm |
| 10705034243184 | ISOLA SPINE SYSTEM ANGLED SLOTTED CONNECTOR 6.35mm |
| 10705034003627 | ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm |
| 10705034003405 | ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 6.35mm |
| 10705034003399 | ISOLA SPINE SYSTEM STRAIGHT SLOTTED CONNECTOR 6.35mm |
| 10705034001630 | ISOLA SPINE SYSTEM HOOK ROTATOR |
| 10705034001524 | ISOLA SPINE SYSTEM OPEN HOOK CAP REMOVER |
| 10705034011295 | ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm |
| 10705034005782 | ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 9.5mm |
| 10705034005737 | ISOLA SPINE SYSTEM OPEN HOOK 4.75 x 8.0mm |
| 10705034156460 | ISOLA SPINE SYSTEM EXTENDED SLOTTED CONNECTOR 5.5mm |
| 10705034012940 | ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm |
| 10705034012919 | ISOLA SPINE SYSTEM SPINAL ROD 4.75 x 457.2mm |
| 10705034011400 | ISOLA SPINE SYSTEM EASY ROD 6.35 x 457.2mm |
| 10705034011394 | ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 457.2mm |
| 10705034011370 | ISOLA SPINE SYSTEM SPINAL ROD 6.35 x 609.6mm |
| 10705034005126 | ISOLA SPINE SYSTEM MCC J-HOOK 6.35mm |
| 10705034005119 | ISOLA SPINE SYSTEM MCC PLATE 50-70mm |
| 10705034005096 | ISOLA SPINE SYSTEM MCC PLATE 30-50mm |
| 10705034005072 | ISOLA SPINE SYSTEM MCC PLATE 15-30mm |
| 10705034005065 | ISOLA SPINE SYSTEM MCC PLATE 10-25mm |
| 10705034001456 | ISOLA SYSTEM MINI HEXDRIVER 3.18mm |
| 10705034001340 | ISOLA SPINE SYSTEM GONIOMETER |
| 10705034240718 | ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 4.75mm |
| 10705034004853 | ISOLA SPINE SYSTEM BONE MARKER-DOUBLE BARREL |
| 10705034004846 | ISOLA SPINE SYSTEM BONE MARKER-SINGLE BARREL |
| 10705034001722 | ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER |
| 10705034001715 | ISOLA SPINE SYSTEM TOGGLE FREE HOOK HOLDER |
| 10705034001685 | ISOLA SPINE SYSTEM RING HANDLE ROD HOLDER 4.75mm |
| 10705034001548 | ISOLA SPINE SYSTEM OPEN HOOK HOLDER |
| 10705034001425 | ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 6.35mm |
| 10705034001395 | ISOLA SPINE SYSTEM SMALL STRAIGHT ROD HOLDER 4.75mm |
| 10705034001371 | ISOLA SPINE SYSTEM POWERGRIP ROD HOLDER 4.75mm |
| 10705034001364 | ISOLA SPINE SYSTEM STRAIGHT ROD HOLDER 6.35mm |
| 10705034001319 | ISOLA SPINE SYSTEM ROD HOLDER 6.35mm |
| 10705034001302 | ISOLA SPINE SYSTEM ROD HOLDER 4.75mm |
| 10705034184838 | ISOLA SPINE SYSTEM HOOK CASE |
| 10705034184821 | ISOLA SPINE SYSTEM LOW BACK AUXILLARY TRAY |
| 10705034004891 | ISOLA SPINE SYSTEM IMPLANT/INSTRUMENT CASE |
| 10705034001203 | ISOLA SPINE SYSTEM OPEN CAP MANIPULATOR 4.75mm |
| 10705034001180 | ISOLA SPINE SYSTEM HOOK COMPRESSOR |
| 10705034001173 | ISOLA SPINE SYSTEM COMPRESSOR |
| 10705034296128 | ISOLA SPINE SYSTEM AWL 90 DEGREES |
| 10705034001555 | ISOLA SPINE SYSTEM SPINAL AWL |
| 10705034241524 | ISOLA SPINE SYSTEM SET SCREW 3.17mm |
| 10705034184845 | ISOLA SPINE SYSTEM TAP 10mm 40-120mm Plus or Minus 1.00 Percent |
| 10705034001616 | ISOLA SPINE SYSTEM BONE SCREW TAP 8.5mm 40-70mm Plus or Minus 1.00 Percent |
| 10705034001609 | ISOLA SPINE SYSTEM BONE SCREW TAP 7.75mm 40-70mm Plus or Minus 1.00 Percent |
| 10705034001593 | ISOLA SPINE SYSTEM BONE SCREW TAP 7mm 40-70mm Plus or Minus 1.00 Percent |
| 10705034001586 | ISOLA 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 88676041 not registered Live/Pending |
Brindco International Beers Pvt Ltd 2019-10-31 |
 ISOLA 88142586 not registered Dead/Abandoned |
Isola Foods LLC 2018-10-04 |
 ISOLA 87834525 not registered Dead/Abandoned |
Isola & Co 2018-03-14 |
 ISOLA 87524062 5473596 Live/Registered |
AMT Group Bahamas Limited 2017-07-11 |
 ISOLA 87144151 5344036 Live/Registered |
Mia Cole, LLC 2016-08-19 |
 ISOLA 85686746 4409690 Live/Registered |
Isola USA Corp. 2012-07-25 |
 ISOLA 85686504 4409689 Live/Registered |
Isola USA Corp. 2012-07-25 |
 ISOLA 85355297 not registered Dead/Abandoned |
Marchesa Holdings, LLC 2011-06-24 |
 ISOLA 85355278 not registered Dead/Abandoned |
Marchesa Holdings, LLC 2011-06-24 |
 ISOLA 85355267 not registered Dead/Abandoned |
Marchesa Holdings, LLC 2011-06-24 |
 ISOLA 79151222 not registered Dead/Abandoned |
Isola Swim Pty Limited 2014-06-04 |
 ISOLA 77811931 4339009 Live/Registered |
Columbia Insurance Company 2009-08-25 |
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