8 Degree Lordotic, Opticage Expandable Interbody Implant 9101-21

GUDID 00011954013448

22mm Width x 45mm Length by 11mm-16mm Footprint Length

INTERVENTIONAL SPINE, INC

Metallic spinal interbody fusion cage

• Primary Device ID: 00011954013448
• NIH Device Record Key: 8e337d07-5315-462d-a21f-aeaea4f2d8d3
• Commercial Distribution Discontinuation: 2016-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 8 Degree Lordotic, Opticage Expandable Interbody Implant
• Version Model Number: 9101-21
• Catalog Number: 9101-21
• Company DUNS: 017663522
• Company Name: INTERVENTIONAL SPINE, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 800-497-0484
• Email: www.cs@i-spineinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00011954013448 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-05-25

On-Brand Devices [8 Degree Lordotic, Opticage Expandable Interbody Implant]

• 00811954013462: 22mm Width x 55mm Length by 11mm-16mm Footprint Length
• 00811954013455: 22mm Width x 50mm Length by 11mm-16mm Footprint Length
• 00811954013431: 22mm Width x 40mm Length by 11mm-16mm Footprint Length
• 00811954013424: 18mm Width x 55mm Length by 11mm-16mm Footprint Length
• 00811954013417: 18mm Width x 50mm Length by 11mm-16mm Footprint Length
• 00811954013400: 18mm Width x 45mm Length by 11mm-16mm Footprint Length
• 00811954013394: 18mm Width x 40mm Length by 11mm-16mm Footprint Length
• 00811954013387: 16mm Width x 55mm Length by 11mm-16mm Footprint Length
• 00811954013370: 16mm Width x 50mm Length by 11mm-16mm Footprint Length
• 00811954013363: 16mm Width x 45mm Length by 11mm-16mm Footprint Length
• 00811954013356: 16mm Width x 40mm Length by 11mm-16mm Footprint Length
• 00811954013349: 12mm Width x 30mm Length by 11mm-16mm Footprint Length
• 00811954013332: 12mm Width x 26mm Length by 11mm-16mm Footprint Length
• 00811954013325: 12mm Width x 21mm Length by 11mm-16mm Footprint Length
• 00811954013318: 11mm Width x 30mm Length by 11mm-16mm Footprint Length
• 00811954013301: 11mm Width x 26mm Length by 11mm-16mm Footprint Length
• 00811954013295: 11mm Width x 21mm Length by 11mm-16mm Footprint Length
• 00811954013288: 10mm Width x 30mm Length by 11mm-16mm Footprint Length
• 00811954013271: 10mm Width x 26mm Length by 11mm-16mm Footprint Length
• 00811954013264: 10mm Width x 21mm Length by 11mm-16mm Footprint Length
• 00811954013257: 9mm Width x 30mm Length by 11mm-16mm Footprint Length
• 00811954013240: 9mm Width x 26mm Length by 11mm-16mm Footprint Length
• 00811954013233: 9mm Width x 21mm Length by 11mm-16mm Footprint Length
• 00011954013448: 22mm Width x 45mm Length by 11mm-16mm Footprint Length