Salvo™ Spine System 11-6531
GUDID 10840642132991
Locking Screw, 4.75 mm
Spine Wave, Inc.
Spinal bone set screw| Primary Device ID | 10840642132991 |
| NIH Device Record Key | 1883235b-d10a-4fc4-9ed8-ebada883935a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salvo™ Spine System |
| Version Model Number | 11-6531 |
| Catalog Number | 11-6531 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642132991 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182954
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
[10840642132991]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-03 |
| Device Publish Date | 2019-08-23 |
On-Brand Devices [Salvo™ Spine System ]
| 10840642142150 | Yoke Inserter, 4.75 mm |
| 10840642132991 | Locking Screw, 4.75 mm |
| 10840642133073 | 4.5 x 40 mm Bone Screw, Cannulated 2 mm Pitch |
| 10840642133066 | 4.5 x 35 mm Bone Screw, Cannulated 2 mm Pitch |
| 10840642133059 | 4.5 x 30 mm Bone Screw, Cannulated 2 mm Pitch |
| 10840642133042 | 4.5 x 25 mm Bone Screw, Cannulated 2 mm Pitch |
| 10840642133028 | Cross Connector, 4.75 mm, Large |
| 10840642133011 | Cross Connector, 4.75 mm, Medium |
| 10840642133004 | Cross Connector, 4.75 mm, Small |
| 10840642139242 | 4.75 x 120 mm Rod, Curved, CoCr |
| 10840642139228 | 4.75 x 110 mm Rod, Curved, CoCr |
| 10840642139204 | 4.75 x 100 mm Rod, Curved, CoCr |
| 10840642139181 | 4.75 x 90 mm Rod, Curved, CoCr |
| 10840642139167 | 4.75 x 80 mm Rod, Curved, CoCr |
| 10840642139150 | 4.75 x 75 mm Rod, Curved, CoCr |
| 10840642139143 | 4.75 x 70 mm Rod, Curved, CoCr |
| 10840642139136 | 4.75 x 65 mm Rod, Curved, CoCr |
| 10840642139129 | 4.75 x 60 mm Rod, Curved, CoCr |
| 10840642139112 | 4.75 x 55 mm Rod, Curved, CoCr |
| 10840642139105 | 4.75 x 50 mm Rod, Curved, CoCr |
| 10840642139099 | 4.75 x 45 mm Rod, Curved, CoCr |
| 10840642139082 | 4.75 x 40 mm Rod, Curved, CoCr |
| 10840642139075 | 4.75 x 35 mm Rod, Curved, CoCr |
| 10840642139068 | 4.75 x 30 mm Rod, Curved, CoCr |
| 10840642139051 | 4.75 x 25 mm Rod, Curved, CoCr |
| 10840642139044 | 4.75 x 300 mm Rod, Straight, CoCr |
| 10840642138146 | 4.75 x 120 mm Rod, Curved, Ti |
| 10840642138122 | 4.75 x 110 mm Rod, Curved, Ti |
| 10840642138108 | 4.75 x 100 mm Rod, Curved, Ti |
| 10840642138085 | 4.75 x 90 mm Rod, Curved, Ti |
| 10840642138061 | 4.75 x 80 mm Rod, Curved, Ti |
| 10840642138054 | 4.75 x 75 mm Rod, Curved, Ti |
| 10840642138047 | 4.75 x 70 mm Rod, Curved, Ti |
| 10840642138030 | 4.75 x 65 mm Rod, Curved, Ti |
| 10840642138023 | 4.75 x 60 mm Rod, Curved, Ti |
| 10840642138016 | 4.75 x 55 mm Rod, Curved, Ti |
| 10840642138009 | 4.75 x 50 mm Rod, Curved, Ti |
| 10840642137996 | 4.75 x 45 mm Rod, Curved, Ti |
| 10840642137989 | 4.75 x 40 mm Rod, Curved, Ti |
| 10840642137972 | 4.75 x 35 mm Rod, Curved, Ti |
| 10840642137965 | 4.75 x 30 mm Rod, Curved, Ti |
| 10840642137958 | 4.75 x 25 mm Rod, Curved, Ti |
| 10840642134582 | 7.5 x 50 mm Bone Screw, 2 mm Pitch |
| 10840642134575 | 7.5 x 45 mm Bone Screw, 2 mm Pitch |
| 10840642134568 | 7.5 x 40 mm Bone Screw, 2 mm Pitch |
| 10840642134551 | 7.5 x 35 mm Bone Screw, 2 mm Pitch |
| 10840642134544 | 7.5 x 30 mm Bone Screw, 2 mm Pitch |
| 10840642134537 | 7.5 x 25 mm Bone Screw, 2 mm Pitch |
| 10840642134490 | 6.5 x 50 mm Bone Screw, 2 mm Pitch |
| 10840642134483 | 6.5 x 45 mm Bone Screw, 2 mm Pitch |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.