SeaSpine Expandable Interbody 98-2005

GUDID 10889981120764

Inserter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10889981120764
NIH Device Record Key758eadf4-05fd-4679-bb98-336a2db3a8a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeaSpine Expandable Interbody
Version Model Number98-2005
Catalog Number98-2005
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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
GS110889981120764 [Primary]

FDA Product Code

HXXSCREWDRIVER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


[10889981120764]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-05-20

On-Brand Devices [SeaSpine Expandable Interbody]

1088998112386430mm Implant Caddy
1088998112385726mm Implant Caddy
1088998112384022mm Implant Caddy
10889981123833Implant Tray
10889981123826Instrument Tray
10889981123819Guide Hex Rod
10889981123802Bone Funnel
10889981123796Driver
1088998112378918mm Trial (22x10mm, 0 deg)
1088998112377217mm Trial (22x10mm, 0 deg)
1088998112376516mm Trial (22x10mm, 0 deg)
1088998112375815mm Trial (22x10mm, 0 deg)
1088998112374114mm Trial (22x10mm, 0 deg)
1088998112373413mm Trial (22x10mm, 0 deg)
1088998112372712mm Trial (22x10mm, 0 deg)
1088998112371011mm Trial (22x10mm, 0 deg)
1088998112370310mm Trial (22x10mm, 0 deg)
108899811236979mm Trial (22x10mm, 0 deg)
108899811236808mm Trial (22x10mm, 0 deg)
108899811236736mm Starter Trial
1088998112366612mm Wide Removal Tool
10889981123659Removal Tool
10889981123642Expansion Driver
10889981123635Expansion Driver
10889981123628Inserter
10889981123611Inserter
10889981123604IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG
10889981123598IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG
10889981123581IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG
10889981123574IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG
10889981123567IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG
10889981123550IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG
10889981123543IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG
10889981123536IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG
10889981123529IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG
10889981123512IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG
10889981123505IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG
10889981123499IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG
10889981123482IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
10889981123475IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
10889981123468IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG
10889981123451IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG
10889981123444IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG
10889981123437IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG
10889981123420Expandable IBD Implants
10889981120764Inserter

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