Indus®
GUDID 00190361001317
Invue Max, Three Level ACP, 54mm
SPINEFRONTIER, INC.
Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00190361001317 |
| NIH Device Record Key | e5e79628-a244-4426-b1e0-9a17850c3bf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indus® |
| Version Model Number | 01-71006-54 |
| Company DUNS | 002003243 |
| Company Name | SPINEFRONTIER, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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
Device Dimensions
| Length | 54 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
| Width | 16.5 Millimeter |
| Length | 54 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361001317 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121060
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
[00190361001317]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-04-15 |
On-Brand Devices [Indus®]
| 00190361039525 | 12mm Trial Drill Guide, Lordotic |
| 00190361039518 | 11mm Trial Drill Guide, Lordotic |
| 00190361039501 | 10mm Trial Drill Guide, Lordotic |
| 00190361039495 | 9mm Trial Drill Guide, Lordotic |
| 00190361039488 | 8mm Trial Drill Guide, Lordotic |
| 00190361039471 | 7mm Trial Drill Guide, Lordotic |
| 00190361039464 | 6mm Trial Drill Guide, Lordotic |
| 00190361039457 | 5mm Trial Drill Guide, Lordotic |
| 00190361039440 | Invue Trial Drill Guide, 12mm |
| 00190361039433 | Invue Trial Drill Guide, 11mm |
| 00190361039426 | Invue Trial Drill Guide, 10mm |
| 00190361039419 | Invue Trial Drill Guide, 9mm |
| 00190361039402 | Invue Trial Drill Guide, 8mm |
| 00190361039396 | Invue Trial Drill Guide, 7mm |
| 00190361039389 | Invue Trial Drill Guide, 6mm |
| 00190361039372 | Invue Trial Drill Guide, 5mm |
| 00190361002130 | Invue, Self Drilling Screw, Tapered, 4.2 x 16mm |
| 00190361002123 | Invue, Self Drilling Screw, Tapered, 4.2 x 14mm |
| 00190361002116 | Invue, Self Drilling Screw, Tapered, 4.2 x 12mm |
| 00190361002109 | Invue, Self Tapping Screw, Tapered, 4.2 x 16mm |
| 00190361002093 | Invue, Self Tapping Screw, Tapered, 4.2 x 14mm |
| 00190361002086 | Invue, Self Tapping Screw, Tapered, 4.2 x 12mm |
| 00190361002079 | Invue, Self Tapping Screw, 4.0 x 16mm |
| 00190361002062 | Invue, Self Tapping Screw, 4.0 x 14mm |
| 00190361002055 | Invue, Self Tapping Screw, 4.0 x 12mm |
| 00190361002048 | Invue, Cervical Plate, Four Level, 61mm |
| 00190361002031 | Invue, Cervical Plate, Four Level, 65mm |
| 00190361002024 | Invue, Cervical Plate, Four Level, 109mm |
| 00190361002017 | Invue, Cervical Plate, Four Level, 105mm |
| 00190361002000 | Invue, Cervical Plate, Four Level, 101mm |
| 00190361001997 | Invue, Cervical Plate, Four Level, 97mm |
| 00190361001980 | Invue, Cervical Plate, Four Level, 93mm |
| 00190361001973 | Invue, Cervical Plate, Four Level, 89mm |
| 00190361001966 | Invue, Cervical Plate, Four Level, 85mm |
| 00190361001959 | Invue, Cervical Plate, Four Level, 81mm |
| 00190361001942 | Invue, Cervical Plate, Four Level, 77mm |
| 00190361001935 | Invue, Cervical Plate, Four Level, 73mm |
| 00190361001928 | Invue, Cervical Plate, Four Level, 69mm |
| 00190361001911 | Invue, Cervical Plate, Three Level, 48mm |
| 00190361001904 | Invue, Cervical Plate, Three Level, 51mm |
| 00190361001898 | Invue, Cervical Plate, Three Level, 78mm |
| 00190361001881 | Invue, Cervical Plate, Three Level, 75mm |
| 00190361001874 | Invue, Cervical Plate, Three Level, 72mm |
| 00190361001867 | Invue, Cervical Plate, Three Level, 69mm |
| 00190361001850 | Invue, Cervical Plate, Three Level, 66mm |
| 00190361001843 | Invue, Cervical Plate, Three Level, 63mm |
| 00190361001836 | Invue, Cervical Plate, Three Level, 60mm |
| 00190361001829 | Invue, Cervical Plate, Three Level, 57mm |
| 00190361001812 | Invue, Cervical Plate, Three Level, 54mm |
| 00190361001805 | Invue, Cervical Plate, Two Level, 33mm |
Trademark Results [Indus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INDUS 97499843 not registered Live/Pending |
Alcon Inc. 2022-07-12 |
 INDUS 90851211 not registered Live/Pending |
Indus Road & Bridge, Inc. 2021-07-27 |
 INDUS 90511989 not registered Live/Pending |
Ma Chuchao 2021-02-04 |
 INDUS 90064400 not registered Live/Pending |
Sealcoating, Inc. 2020-07-21 |
 INDUS 88576274 not registered Live/Pending |
Thetford Corporation 2019-08-13 |
 INDUS 88330463 not registered Live/Pending |
Danvita India Pvt Ltd 2019-03-07 |
 INDUS 88016024 not registered Live/Pending |
Sealcoating, Inc. 2018-06-26 |
 INDUS 88011771 not registered Live/Pending |
MRL TYRES LIMITED 2018-06-22 |
 INDUS 87730219 5625670 Live/Registered |
Indus International FZC 2017-12-21 |
 INDUS 86273364 4774016 Live/Registered |
The Coleman Company, Inc. 2014-05-06 |
 INDUS 85697842 not registered Dead/Abandoned |
Soulcake, Inc. 2012-08-08 |
 INDUS 78620122 3082581 Live/Registered |
Indus Capital Partners, LLC 2005-04-29 |
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