Integra Expandable Interbody 82-2608

GUDID 10889981049270

IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTI

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981049270
• NIH Device Record Key: ddb145dc-ba42-48f0-929a-c1ee82c591b2
• Commercial Distribution Discontinuation: 2018-01-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra Expandable Interbody
• Version Model Number: 82-2608
• Catalog Number: 82-2608
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981049270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133418

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889981049270]

Moist Heat or Steam Sterilization

[10889981049270]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Integra Expandable Interbody]

• 10889981062255: Expandable IBD Implants
• 10889981049645: 30mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic
• 10889981049638: 26mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic
• 10889981049621: 22mm Implant Caddy. The Integra Expandable IBD System consists of lumbar interbody fusion device
• 10889981049614: Implant Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu
• 10889981049607: Instrument Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices m
• 10889981049591: Guide Hex Rod. The Integra Expandable IBD System consists of lumbar interbody fusion devices man
• 10889981049584: Bone Funnel. The Integra Expandable IBD System consists of lumbar interbody fusion devices manuf
• 10889981049577: Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactur
• 10889981049560: 18mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049553: 17mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049546: 16mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049539: 15mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049522: 14mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049515: 13mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049508: 12mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049492: 11mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049485: 10mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi
• 10889981049478: 9mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio
• 10889981049461: 8mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio
• 10889981049454: 6mm Starter Trial. The Integra Expandable IBD System consists of lumbar interbody fusion devices
• 10889981049447: 12mm Wide Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion de
• 10889981049430: Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu
• 10889981049423: Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices
• 10889981049416: Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices
• 10889981049409: Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact
• 10889981049393: Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact
• 10889981049386: IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049379: IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049362: IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
• 10889981049355: IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049348: IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049331: IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
• 10889981049324: IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049317: IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049300: IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
• 10889981049294: IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049287: IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049270: IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
• 10889981049263: IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049256: IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049249: IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba
• 10889981049232: IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049225: IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb
• 10889981049218: IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba