CapSure® Spine System 11-3445

GUDID 10840642104752

PS2 Screw 4.5mm x 45mm

Spine Wave, Inc.

Spinal bone screw, non-bioabsorbable
Primary Device ID10840642104752
NIH Device Record Key8e3c591e-bc10-4715-b696-08b59dab569d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapSure® Spine System
Version Model Number11-3445
Catalog Number11-3445
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
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 Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter
Outer Diameter4.5 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642104752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

[10840642104752]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-09
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
10840642104516Rod Straight 5.5 x 300mm
10840642104509Rod Straight 5.5 x 95mm
10840642104493Rod Straight 5.5 x 90mm
10840642104486Rod Straight 5.5 x 85mm
10840642104479Rod Straight 5.5 x 80mm
10840642104462Rod Straight 5.5 x 75mm
10840642104455Rod Straight 5.5 x 70mm
10840642104448Rod Straight 5.5 x 65mm
10840642104431Rod Straight 5.5 x 60mm
10840642104424Rod Straight 5.5 x 55mm
10840642104417Rod Straight 5.5 x 50mm
10840642104400Rod Straight 5.5 x 45mm
10840642104394Rod Straight 5.5 x 40mm
10840642104387Rod Straight 5.5 x 35mm
10840642104370Rod Straight 5.5 x 30mm
10840642104363Rod Straight 5.5 x 140mm
10840642104356Rod Straight 5.5 x 130mm
10840642104349Rod Straight 5.5 x 120mm

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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