Balboa™ 19-5535

GUDID 10889981051822

Buttress Screw, 5.5x35mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable
Primary Device ID10889981051822
NIH Device Record Keye46f16fa-2f46-4fda-a30d-dc15e94ff791
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalboa™
Version Model Number19-5535
Catalog Number19-5535
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
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 Usefalse
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

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981051822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


[10889981051822]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Balboa™]

10889981062187Balboa Implant
10889981051846Buttress Screw 6.5x25mm
10889981051839Buttress Screw 6.5x20mm
10889981051822Buttress Screw, 5.5x35mm
10889981051815Buttress Screw, 5.5x30mm
10889981051808Buttress Screw, 5.5x25mm
10889981051792Buttress Screw, 5.5x20mm
10889981051785Buttress Plate, 15x24mm
10889981051778Buttress Plate, 15x19mm

Trademark Results [Balboa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BALBOA
BALBOA
98353495 not registered Live/Pending
Vanderhall Motor Works, Inc.
2024-01-11
BALBOA
BALBOA
86716957 5074537 Live/Registered
Arangold Corporation
2015-08-06
BALBOA
BALBOA
85215495 not registered Dead/Abandoned
Lamar Branch
2011-01-11
BALBOA
BALBOA
85005568 3902204 Live/Registered
Hay House, Inc.
2010-04-02
BALBOA
BALBOA
85005565 3971708 Live/Registered
Hay House, Inc.
2010-04-02
BALBOA
BALBOA
85005561 3971707 Live/Registered
Hay House, Inc.
2010-04-02
BALBOA
BALBOA
78653816 not registered Dead/Abandoned
Branch, Lamar
2005-06-20
BALBOA
BALBOA
78618804 3410408 Live/Registered
BALBOA WINERY, LLC
2005-04-28
BALBOA
BALBOA
77975675 3481992 Dead/Cancelled
Abercrombie & Fitch Trading Co.
2007-03-29
BALBOA
BALBOA
77828727 3855747 Live/Registered
Balboa Insurance Company
2009-09-17
BALBOA
BALBOA
77307300 not registered Dead/Abandoned
Anlin Industries, Inc.
2007-10-18
BALBOA
BALBOA
77280048 3758061 Live/Registered
BALBOA WATER GROUP, LLC
2007-09-14

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