Sniper® Spine System 11-4100

GUDID 10840642105858

Rod Curved 5.5 x 100mm

Spine Wave, Inc.

Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod Bone-screw internal spinal fixation system rod
Primary Device ID10840642105858
NIH Device Record Keyd23faeff-6fd1-46ac-8c6e-73b58b11b5a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSniper® Spine System
Version Model Number11-4100
Catalog Number11-4100
Company DUNS067789763
Company NameSpine Wave, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com

Device Dimensions

Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter
Outer Diameter5.5 Millimeter
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642105858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-10
Device Publish Date2015-10-24

On-Brand Devices [Sniper® Spine System]

10840642130041Sniper® Tap, 8.0mm, NAV-M
10840642130034Sniper® Tap, 7.5mm, NAV-M
10840642130027Sniper® Tap, 7.0mm, NAV-M
10840642130010Sniper® Tap, 6.5mm, NAV-M
10840642130003Sniper® Tap, 6.0mm, NAV-M
10840642129991Sniper® Tap, 5.5mm, NAV-M
10840642129984Sniper® Tap, 5.0mm, NAV-M
10840642129977Sniper® Tap, 4.5mm, NAV-M
10840642129960Sniper® Tap, 4.0mm, NAV-M
10840642129953Sniper® XT Screwdriver, NAV-M
10840642129946Sniper® Mini-Open Screwdriver, NAV-M
10840642129939Sniper® Screwdriver, NAV-M
10840642119022Cannulated Pedicle Screw Reduction Tab 10.5 mm x 130 mm
10840642119015Cannulated Pedicle Screw Reduction Tab 10.5 mm x 120 mm
10840642119008Cannulated Pedicle Screw Reduction Tab 10.5 mm x 110 mm
10840642118995Cannulated Pedicle Screw Reduction Tab 10.5 mm x 100 mm
10840642118988Cannulated Pedicle Screw Reduction Tab 10.5 mm x 95 mm
10840642118971Cannulated Pedicle Screw Reduction Tab 10.5 mm x 90 mm
10840642118964Cannulated Pedicle Screw Reduction Tab 10.5 mm x 85 mm
10840642118957Cannulated Pedicle Screw Reduction Tab 10.5 mm x 80 mm
10840642118940Cannulated Pedicle Screw Reduction Tab 10.5 mm x 75 mm
10840642118933Cannulated Pedicle Screw Reduction Tab 10.5 mm x 70 mm
10840642118926Cannulated Pedicle Screw Reduction Tab 10.5 mm x 65 mm
10840642118919Cannulated Pedicle Screw Reduction Tab 10.5 mm x 60 mm
10840642118902Cannulated Pedicle Screw Reduction Tab 10.5 mm x 55 mm
10840642118896Cannulated Pedicle Screw Reduction Tab 10.5 mm x 50 mm
10840642118889Cannulated Pedicle Screw Reduction Tab 10.5 mm x 45 mm
10840642118872Cannulated Pedicle Screw Reduction Tab 10.5 mm x 40 mm
10840642118865Cannulated Pedicle Screw Reduction Tab 10.5 mm x 35 mm
10840642118858Cannulated Pedicle Screw Reduction Tab 10.5 mm x 30 mm
10840642118841Cannulated Pedicle Screw Reduction Tab 9.5 mm x 140 mm
10840642118834Cannulated Pedicle Screw Reduction Tab 9.5 mm x 130 mm
10840642118827Cannulated Pedicle Screw Reduction Tab 9.5 mm x 120 mm
10840642118810Cannulated Pedicle Screw Reduction Tab 9.5 mm x 110 mm
10840642118803Cannulated Pedicle Screw Reduction Tab 9.5 mm x 100 mm
10840642118797Cannulated Pedicle Screw Reduction Tab 9.5 mm x 95 mm
10840642118780Cannulated Pedicle Screw Reduction Tab 9.5 mm x 90 mm
10840642118773Cannulated Pedicle Screw Reduction Tab 9.5 mm x 85 mm
10840642118766Cannulated Pedicle Screw Reduction Tab 9.5 mm x 80 mm
10840642118759Cannulated Pedicle Screw Reduction Tab 9.5 mm x 75 mm
10840642118742Cannulated Pedicle Screw Reduction Tab 9.5 mm x 70 mm
10840642118735Cannulated Pedicle Screw Reduction Tab 9.5 mm x 65 mm
10840642118728Cannulated Pedicle Screw Reduction Tab 9.5 mm x 60 mm
10840642118711Cannulated Pedicle Screw Reduction Tab 9.5 mm x 55 mm
10840642118704Cannulated Pedicle Screw Reduction Tab 9.5 mm x 50 mm
10840642118698Cannulated Pedicle Screw Reduction Tab 9.5 mm x 45 mm
10840642118681Cannulated Pedicle Screw Reduction Tab 9.5 mm x 40 mm
10840642118674Cannulated Pedicle Screw Reduction Tab 9.5 mm x 35 mm
10840642118667Cannulated Pedicle Screw Reduction Tab 9.5 mm x 30 mm
10840642118650Cannulated Pedicle Screw Reduction Tab 8.5 mm x 140 mm

Trademark Results [Sniper]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SNIPER
SNIPER
98127807 not registered Live/Pending
Thomes, Richard
2023-08-11
SNIPER
SNIPER
97498221 not registered Live/Pending
SUZHOU SNIPER MEDICAL TECHNOLOGIES CO.,LTD
2022-07-11
SNIPER
SNIPER
97161225 not registered Live/Pending
CyberActive Technologies LLC
2021-12-07
SNIPER
SNIPER
90361543 not registered Live/Pending
Thomes, Richard
2020-12-06
SNIPER
SNIPER
90182415 not registered Live/Pending
Intense, LLC
2020-09-15
SNIPER
SNIPER
90083003 not registered Live/Pending
ANYTHING POSSIBLE, LLC
2020-07-30
SNIPER
SNIPER
87717557 not registered Live/Pending
Invenra, Inc.
2017-12-12
SNIPER
SNIPER
87606105 not registered Dead/Abandoned
DaVinci CSJ, LLC
2017-09-13
SNIPER
SNIPER
87584640 not registered Live/Pending
VORLO IP, LLC
2017-08-25
SNIPER
SNIPER
87270108 5245228 Live/Registered
ZEROPLUS TECHNOLOGY CO., LTD.
2016-12-15
SNIPER
SNIPER
86896264 5031935 Live/Registered
KSE SPORTSMAN MEDIA, INC.
2016-02-03
SNIPER
SNIPER
86758105 5370535 Live/Registered
MUSKOKA MILLWRIGHTING & MACHINING LTD.
2015-09-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.