Sniper® Spine System 11-4100
GUDID 10840642105858
Rod Curved 5.5 x 100mm
Spine Wave, Inc.
Bone-screw internal spinal fixation system rod| Primary Device ID | 10840642105858 |
| NIH Device Record Key | d23faeff-6fd1-46ac-8c6e-73b58b11b5a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sniper® Spine System |
| Version Model Number | 11-4100 |
| Catalog Number | 11-4100 |
| 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 |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 100 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642105858 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100605
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
[10840642105858]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-10 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [Sniper® Spine System]
| 10840642130041 | Sniper® Tap, 8.0mm, NAV-M |
| 10840642130034 | Sniper® Tap, 7.5mm, NAV-M |
| 10840642130027 | Sniper® Tap, 7.0mm, NAV-M |
| 10840642130010 | Sniper® Tap, 6.5mm, NAV-M |
| 10840642130003 | Sniper® Tap, 6.0mm, NAV-M |
| 10840642129991 | Sniper® Tap, 5.5mm, NAV-M |
| 10840642129984 | Sniper® Tap, 5.0mm, NAV-M |
| 10840642129977 | Sniper® Tap, 4.5mm, NAV-M |
| 10840642129960 | Sniper® Tap, 4.0mm, NAV-M |
| 10840642129953 | Sniper® XT Screwdriver, NAV-M |
| 10840642129946 | Sniper® Mini-Open Screwdriver, NAV-M |
| 10840642129939 | Sniper® Screwdriver, NAV-M |
| 10840642119022 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 130 mm |
| 10840642119015 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 120 mm |
| 10840642119008 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 110 mm |
| 10840642118995 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 100 mm |
| 10840642118988 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 95 mm |
| 10840642118971 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 90 mm |
| 10840642118964 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 85 mm |
| 10840642118957 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 80 mm |
| 10840642118940 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 75 mm |
| 10840642118933 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 70 mm |
| 10840642118926 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 65 mm |
| 10840642118919 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 60 mm |
| 10840642118902 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 55 mm |
| 10840642118896 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 50 mm |
| 10840642118889 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 45 mm |
| 10840642118872 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 40 mm |
| 10840642118865 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 35 mm |
| 10840642118858 | Cannulated Pedicle Screw Reduction Tab 10.5 mm x 30 mm |
| 10840642118841 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 140 mm |
| 10840642118834 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 130 mm |
| 10840642118827 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 120 mm |
| 10840642118810 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 110 mm |
| 10840642118803 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 100 mm |
| 10840642118797 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 95 mm |
| 10840642118780 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 90 mm |
| 10840642118773 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 85 mm |
| 10840642118766 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 80 mm |
| 10840642118759 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 75 mm |
| 10840642118742 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 70 mm |
| 10840642118735 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 65 mm |
| 10840642118728 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 60 mm |
| 10840642118711 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 55 mm |
| 10840642118704 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 50 mm |
| 10840642118698 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 45 mm |
| 10840642118681 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 40 mm |
| 10840642118674 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 35 mm |
| 10840642118667 | Cannulated Pedicle Screw Reduction Tab 9.5 mm x 30 mm |
| 10840642118650 | Cannulated Pedicle Screw Reduction Tab 8.5 mm x 140 mm |
Trademark Results [Sniper]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SNIPER 98127807 not registered Live/Pending |
Thomes, Richard 2023-08-11 |
 SNIPER 97498221 not registered Live/Pending |
SUZHOU SNIPER MEDICAL TECHNOLOGIES CO.,LTD 2022-07-11 |
 SNIPER 97161225 not registered Live/Pending |
CyberActive Technologies LLC 2021-12-07 |
 SNIPER 90361543 not registered Live/Pending |
Thomes, Richard 2020-12-06 |
 SNIPER 90182415 not registered Live/Pending |
Intense, LLC 2020-09-15 |
 SNIPER 90083003 not registered Live/Pending |
ANYTHING POSSIBLE, LLC 2020-07-30 |
 SNIPER 87717557 not registered Live/Pending |
Invenra, Inc. 2017-12-12 |
 SNIPER 87606105 not registered Dead/Abandoned |
DaVinci CSJ, LLC 2017-09-13 |
 SNIPER 87584640 not registered Live/Pending |
VORLO IP, LLC 2017-08-25 |
 SNIPER 87270108 5245228 Live/Registered |
ZEROPLUS TECHNOLOGY CO., LTD. 2016-12-15 |
 SNIPER 86896264 5031935 Live/Registered |
KSE SPORTSMAN MEDIA, INC. 2016-02-03 |
 SNIPER 86758105 5370535 Live/Registered |
MUSKOKA MILLWRIGHTING & MACHINING LTD. 2015-09-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.