Cortera
GUDID 00840311207879
Rod, Ti, MIS Prebent, 5.5x80
Surgalign Spine Technologies, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00840311207879 |
| NIH Device Record Key | 792e3264-07f8-4717-8a95-17e389b4104f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cortera |
| Version Model Number | 150203-55080 |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, 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
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311207879 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221403
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
[00840311207879]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-12 |
| Device Publish Date | 2023-06-02 |
On-Brand Devices [Cortera]
| 00840311209095 | Guidewire, Nitinol, Blunt Tip, 350 |
| 00840311232222 | Reducer, Open Inline, Reduction Pusher |
| 00840311232215 | Reducer, Open Inline |
| 00840311211012 | Reducer, MIS Threaded, SUB, Body |
| 00840311211005 | Reducer, MIS Threaded, SUB, Shaft |
| 00840311240968 | Probe, NAV, Lenke, Iliac, Straight |
| 00840311234196 | Tap, NAV, Iliac, Solid, 12.5 |
| 00840311234189 | Tap, NAV, Iliac, Solid, 11.5 |
| 00840311234172 | Tap, NAV, Iliac, Solid, 10.5 |
| 00840311234165 | Tap, NAV, Iliac, Solid, 9.5 |
| 00840311234158 | Tap, NAV, Iliac, Solid, 8.5 |
| 00840311234141 | Tap, NAV, Iliac, Solid, 8.0 |
| 00840311234134 | Tap, NAV, Iliac, Solid, 7.5 |
| 00840311234127 | Tap, NAV, Iliac, Solid, 7.0 |
| 00840311234110 | Tap, NAV, Iliac, Solid, 6.5 |
| 00840311234103 | Tap, NAV, Iliac, Solid, 6.0 |
| 00840311234097 | Tap, NAV, Iliac, Solid, 5.5 |
| 00840311234080 | Tap, NAV, Iliac, Solid, 5.0 |
| 00840311234073 | Tap, NAV, Iliac, Solid, 4.5 |
| 00840311234066 | Tap, NAV, Iliac, Solid, 4.0 |
| 00840311234059 | Tap, NAV, Open Cann, 12.5 |
| 00840311234042 | Tap, NAV, Open Cann, 11.5 |
| 00840311234035 | Tap, NAV, Open Cann, 10.5 |
| 00840311234028 | Tap, NAV, Open Cann, 9.5 |
| 00840311234011 | Tap, NAV, Open Cann, 8.5 |
| 00840311234004 | Tap, NAV, Open Cann, 8.0 |
| 00840311233991 | Tap, NAV, Open Cann, 7.5 |
| 00840311233984 | Tap, NAV, Open Cann, 7.0 |
| 00840311233977 | Tap, NAV, Open Cann, 6.5 |
| 00840311233960 | Tap, NAV, Open Cann, 6.0 |
| 00840311233953 | Tap, NAV, Open Cann, 5.5 |
| 00840311233946 | Tap, NAV, Open Cann, 5.0 |
| 00840311233939 | Tap, NAV, Open Cann, 4.5 |
| 00840311233922 | Tap, NAV, Open Cann, 4.0 |
| 00840311233526 | Tap, NAV, Cann, 12.5 |
| 00840311233519 | Tap, NAV, Cann, 11.5 |
| 00840311233502 | Tap, NAV, Cann, 10.5 |
| 00840311233496 | Tap, NAV, Cann, 9.5 |
| 00840311233489 | Tap, NAV, Cann, 8.5 |
| 00840311233472 | Tap, NAV, Cann, 8.0 |
| 00840311233465 | Tap, NAV, Cann, 7.5 |
| 00840311233458 | Tap, NAV, Cann, 7.0 |
| 00840311233441 | Tap, NAV, Cann, 6.5 |
| 00840311233434 | Tap, NAV, Cann, 6.0 |
| 00840311233427 | Tap, NAV, Cann, 5.5 |
| 00840311233410 | Tap, NAV, Cann, 5.0 |
| 00840311233403 | Tap, NAV, Cann, 4.5 |
| 00840311233397 | Tap, NAV, Cann, 4.0 |
| 00840311233380 | Tap, NAV, Solid, 12.5 |
| 00840311233373 | Tap, NAV, Solid, 11.5 |
Trademark Results [Cortera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORTERA 97274929 not registered Live/Pending |
Surgalign Spine Technologies, Inc. 2022-02-18 |
 CORTERA 77409043 3737588 Live/Registered |
CORTERA, INC. 2008-02-28 |
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