Mariner Deformity MD2-003024

GUDID 10889981245016

Axial Reducer

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic rod reducer
Primary Device ID10889981245016
NIH Device Record Key90bf84dd-c9c8-40ca-a1b7-dec431c1d713
Commercial Distribution StatusIn Commercial Distribution
Brand NameMariner Deformity
Version Model NumberMD2-003024
Catalog NumberMD2-003024
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
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
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981245016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

[10889981245016]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-02
Device Publish Date2021-05-25

On-Brand Devices [Mariner Deformity]

10889981256319Tri-Flat Tap, 12.5mm
10889981256302Tri-Flat Tap, 12.0mm
10889981256296Tri-Flat Tap, 11.5mm
10889981256289Tri-Flat Tap, 11.0mm
10889981256272Tri-Flat Tap, 10.5mm
10889981256265Tri-Flat Tap, 10.0mm
10889981256258Tri-Flat Tap, 9.5mm
10889981256241Tri-Flat Tap, 9.0mm
10889981256234Tri-Flat Tap, 8.5mm
10889981256227Tri-Flat Tap, 8.0mm
10889981256210Tri-Flat Tap, 7.5mm
10889981256203Tri-Flat Tap, 7.0mm
10889981256197Tri-Flat Tap, 6.5mm
10889981256180Tri-Flat Tap, 6.0mm
10889981256173Tri-Flat Tap, 5.5mm
10889981256166Tri-Flat Tap, 5.0mm
10889981256159Tri-Flat Tap, 4.5mm
10889981256142Tri-Flat Tap, 4.0mm
10889981256135Tri-Flat Tap, 3.5mm
10889981256104Tap, 12.0mm
10889981256098Tap, 11.0mm
10889981256081Tap, 10.0mm
10889981256074Tap, 9.0mm
10889981256067Tap, 8.0mm
10889981256050Tap, 7.5mm
10889981256043Tap, 7.0mm
10889981256036Tap, 6.5mm
10889981256029Tap, 6.0mm
10889981256012Tap, 5.5mm
10889981256005Tap, 5.0mm
10889981255992Tap, 4.5mm
10889981255985Tap, 4.0mm
10889981255978Tap, 3.5mm
10889981255121Tap, 12.5mm
10889981255114Tap, 11.5mm
10889981255107Tap, 10.5mm
10889981255091Tap, 9.5mm
10889981255084Tap, 8.5mm
10889981245016Axial Reducer
10889981256111Closed/Side Polyaxial Screwdriver
10889981235468Polyaxial Head, Closed, Titanium
10889981276225Mariner Deformity Fenestrated Screws
10889981276218Injection Needle Caddy
10889981274214Mariner Deformity Implant Set Insert 2
10889981274207Mariner Deformity Implant Set Insert 1
10889981274191Auxiliary Implant Base
10889981274177Head Caddy
10889981274153Fenestrated Screws, Cannulated
10889981274146Fenestrated Screws, Solid
108899812741397.5mm Uni-Axial Screws
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