CapSure® Spine System 11-3741

GUDID 10840642105131

PS2 Screw 7.5mm x 40mm

Spine Wave, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10840642105131
NIH Device Record Key54e858a7-46a6-49da-ac0f-e777fd8a5d94
Commercial Distribution Discontinuation2020-04-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCapSure® Spine System
Version Model Number11-3741
Catalog Number11-3741
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

Device Dimensions

Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642105131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840642105131]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2015-10-24

On-Brand Devices [CapSure® Spine System]

10840642104929PS2 Screw 5.5mm x 55mm
10840642104905PS2 Screw 5.5mm x 50mm
10840642104882PS2 Screw 5.5mm x 45mm
10840642104868PS2 Screw 5.5mm x 40mm
10840642104844PS2 Screw 5.5mm x 35mm
10840642104820PS2 Screw 5.5mm x 30mm
10840642104806PS2 Screw 5.5mm x 25mm
10840642105216PS2 Screw 7.5mm x 60mm
10840642105193PS2 Screw 7.5mm x 55mm
10840642105179PS2 Screw 7.5mm x 50mm
10840642105155PS2 Screw 7.5mm x 45mm
10840642105131PS2 Screw 7.5mm x 40mm
10840642105117PS2 Screw 7.5mm x 35mm
10840642105094PS2 Screw 7.5mm x 30mm
10840642105049PS2 Screw 6.5mm x 55mm
10840642105025PS2 Screw 6.5mm x 50mm
10840642105001PS2 Screw 6.5mm x 45mm
10840642104981PS2 Screw 6.5mm x 40mm
10840642104967PS2 Screw 6.5mm x 35mm
10840642104943PS2 Screw 6.5mm x 30mm
10840642129922PS3 Tap, 8.0mm, NAV-M
10840642129915PS3 Tap, 7.5mm, NAV-M
10840642129908PS3 Tap, 7.0mm, NAV-M
10840642129892PS3 Tap, 6.5mm, NAV-M
10840642129885PS3 Tap, 6.0mm, NAV-M
10840642129878PS3 Tap, 5.5mm, NAV-M
10840642129861PS3 Tap, 5.0mm, NAV-M
10840642129854PS3 Tap, 4.5mm, NAV-M
10840642129847PS3 Tap, 4.0mm, NAV-M
10840642129830PS3 Screwdriver, NAV-M
10840642129823PS3 Pedicle Probe, Straight, NAV-M
10840642129816PS3 Safety Awl, NAV-M

Trademark Results [CapSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPSURE
CAPSURE
97633688 not registered Live/Pending
Phoenix Brands, LLC
2022-10-15
CAPSURE
CAPSURE
97552678 not registered Live/Pending
Watershed Geosynthetics, LLC
2022-08-17
CAPSURE
CAPSURE
97361218 not registered Live/Pending
SILICON PRAIRIE HOLDINGS, INC,
2022-04-13
CAPSURE
CAPSURE
88400123 not registered Live/Pending
Soteria Group, Inc.
2019-04-24
CAPSURE
CAPSURE
88039533 5735536 Live/Registered
Hy-Vee, Inc.
2018-07-16
CAPSURE
CAPSURE
87897578 not registered Live/Pending
Guardian Medical LLC
2018-04-27
CAPSURE
CAPSURE
87659629 not registered Live/Pending
Orkin Expansion, Inc.
2017-10-25
CAPSURE
CAPSURE
87091281 5244337 Live/Registered
InfiniTek
2016-07-01
CAPSURE
CAPSURE
86222988 4648321 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86222975 4648320 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86222953 4648319 Live/Registered
ENVIRONMENTAL SAMPLING SUPPLY, INC.
2014-03-17
CAPSURE
CAPSURE
86191580 4796131 Live/Registered
C. R. Bard, Inc.
2014-02-12

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