Salvo® Spine System
GUDID 10840642159783
Reduction Yoke Inserter, 5.5/6.0 mm
Spine Wave, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10840642159783 |
| NIH Device Record Key | fd3b543f-82ce-4fa7-8109-b55d16c9e8cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salvo® Spine System |
| Version Model Number | 10-8427 |
| Company DUNS | 067789763 |
| Company Name | Spine Wave, Inc. |
| 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 | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com | |
| Phone | 203-944-9494 |
| info@spinewave.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642159783 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202476
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
[10840642159783]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-18 |
| Device Publish Date | 2021-05-10 |
On-Brand Devices [Salvo® Spine System]
| 10840642153392 | 25mm, 6.0mm Rod, Curved, CoCr |
| 10840642153477 | 65mm, 6.0mm Rod, Curved, CoCr |
| 10840642153460 | 60mm, 6.0mm Rod, Curved, CoCr |
| 10840642153453 | 55mm, 6.0mm Rod, Curved, CoCr |
| 10840642153446 | 50mm, 6.0mm Rod, Curved, CoCr |
| 10840642153439 | 45mm, 6.0mm Rod, Curved, CoCr |
| 10840642153422 | 40mm, 6.0mm Rod, Curved, CoCr |
| 10840642153415 | 35mm, 6.0mm Rod, Curved, CoCr |
| 10840642153408 | 30mm, 6.0mm Rod, Curved, CoCr |
| 10840642153484 | 70mm, 6.0mm Rod, Curved, CoCr |
| 10840642153583 | 120mm, 6.0mm Rod, Curved, CoCr |
| 10840642153569 | 110mm, 6.0mm Rod, Curved, CoCr |
| 10840642153545 | 100mm, 6.0mm Rod, Curved, CoCr |
| 10840642153521 | 90mm, 6.0mm Rod, Curved, CoCr |
| 10840642153507 | 80mm, 6.0mm Rod, Curved, CoCr |
| 10840642153491 | 75mm, 6.0mm Rod, Curved, CoCr |
| 10840642153170 | 120mm, 6.0mm Rod, Straight, CoCr |
| 10840642153156 | 110mm, 6.0mm Rod, Straight, CoCr |
| 10840642153132 | 100mm, 6.0mm Rod, Straight, CoCr |
| 10840642153118 | 90mm, 6.0mm Rod, Straight, CoCr |
| 10840642153095 | 80mm, 6.0mm Rod, Straight, CoCr |
| 10840642153088 | 75mm, 6.0mm Rod, Straight, CoCr |
| 10840642153071 | 70mm, 6.0mm Rod, Straight, CoCr |
| 10840642153064 | 65mm, 6.0mm Rod, Straight, CoCr |
| 10840642153057 | 60mm, 6.0mm Rod, Straight, CoCr |
| 10840642153040 | 55mm, 6.0mm Rod, Straight, CoCr |
| 10840642153033 | 50mm, 6.0mm Rod, Straight, CoCr |
| 10840642153026 | 45mm, 6.0mm Rod, Straight, CoCr |
| 10840642153019 | 40mm, 6.0mm Rod, Straight, CoCr |
| 10840642153002 | 35mm, 6.0mm Rod, Straight, CoCr |
| 10840642152999 | 30mm, 6.0mm Rod, Straight, CoCr |
| 10840642152890 | 120mm, 6.0mm Rod, Curved, Ti |
| 10840642152876 | 110mm, 6.0mm Rod, Curved, Ti |
| 10840642152852 | 100mm, 6.0mm Rod, Curved, Ti |
| 10840642152838 | 90mm, 6.0mm Rod, Curved, Ti |
| 10840642152814 | 80mm, 6.0mm Rod, Curved, Ti |
| 10840642152807 | 75mm, 6.0mm Rod, Curved, Ti |
| 10840642152791 | 70mm, 6.0mm Rod, Curved, Ti |
| 10840642152784 | 65mm, 6.0mm Rod, Curved, Ti |
| 10840642152777 | 60mm, 6.0mm Rod, Curved, Ti |
| 10840642152760 | 55mm, 6.0mm Rod, Curved, Ti |
| 10840642152753 | 50mm, 6.0mm Rod, Curved, Ti |
| 10840642152746 | 45mm, 6.0mm Rod, Curved, Ti |
| 10840642152739 | 40mm, 6.0mm Rod, Curved, Ti |
| 10840642152722 | 35mm, 6.0mm Rod, Curved, Ti |
| 10840642152715 | 30mm, 6.0mm Rod, Curved, Ti |
| 10840642152692 | 55mm, 6.0mm Rod, Straight, Ti |
| 10840642152685 | 60mm, 6.0mm Rod, Straight, Ti |
| 10840642152463 | 120mm, 6.0mm Rod, Straight, Ti |
| 10840642152449 | 110mm, 6.0mm Rod, Straight, Ti |
Trademark Results [Salvo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALVO 90904543 not registered Live/Pending |
S.S. Steiner, Inc. 2021-08-26 |
 SALVO 90320539 not registered Live/Pending |
Flatrock Brands LLC 2020-11-16 |
 SALVO 88781895 not registered Live/Pending |
lauren king salvo 2020-02-01 |
 SALVO 88347085 not registered Live/Pending |
High Threat Concealment, LLC 2019-03-19 |
 SALVO 88072149 not registered Live/Pending |
Digital Iris LLC 2018-08-09 |
 SALVO 87597515 not registered Live/Pending |
Spine Wave, Inc. 2017-09-06 |
 SALVO 87433965 not registered Live/Pending |
26 California Wholesale, Inc. 2017-05-02 |
 SALVO 86816832 5142914 Live/Registered |
Gensco Laboratories, LLC 2015-11-11 |
 SALVO 86801075 5056101 Live/Registered |
Michigan Tube Swagers and Fabricators, Inc. 2015-10-27 |
 SALVO 86566258 5214499 Live/Registered |
Promika, LLC 2015-03-17 |
 SALVO 86389467 5658674 Live/Registered |
Silencerco LLC 2014-09-09 |
 SALVO 86376775 not registered Dead/Abandoned |
Torbay Brands LLC 2014-08-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.