Integra Expandable Interbody 98-2012

GUDID 10889981049447

12mm Wide Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10889981049447
NIH Device Record Key50554f68-8a5c-4681-8973-254997aebb33
Commercial Distribution Discontinuation2018-01-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIntegra Expandable Interbody
Version Model Number98-2012
Catalog Number98-2012
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 Kittrue
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(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
Emailcustsvcspine@seaspine.com
Phone+1(866)942-8698
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 Identifiers

Device Issuing AgencyDevice ID
GS110889981049447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

[10889981049447]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2015-09-24

On-Brand Devices [Integra Expandable Interbody]

10889981062255Expandable IBD Implants
1088998104964530mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic
1088998104963826mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic
1088998104962122mm Implant Caddy. The Integra Expandable IBD System consists of lumbar interbody fusion device
10889981049614Implant Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu
10889981049607Instrument Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices m
10889981049591Guide Hex Rod. The Integra Expandable IBD System consists of lumbar interbody fusion devices man
10889981049584Bone Funnel. The Integra Expandable IBD System consists of lumbar interbody fusion devices manuf
10889981049577Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactur
1088998104956018mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104955317mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104954616mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104953915mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104952214mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104951513mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104950812mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104949211mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
1088998104948510mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
108899810494789mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio
108899810494618mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio
108899810494546mm Starter Trial. The Integra Expandable IBD System consists of lumbar interbody fusion devices
1088998104944712mm Wide Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion de
10889981049430Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu
10889981049423Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices
10889981049416Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices
10889981049409Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact
10889981049393Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact
10889981049386IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049379IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049362IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
10889981049355IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049348IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049331IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
10889981049324IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049317IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049300IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
10889981049294IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049287IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049270IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
10889981049263IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049256IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049249IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
10889981049232IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049225IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
10889981049218IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
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