IsoTis® Facet Fusion Instruments 02-9100-001

GUDID 10889981321826

IsoTis® Facet Fusion Instruments

Seaspine Orthopedics Corporation

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10889981321826
• NIH Device Record Key: 50799dc2-f133-40f1-b5d6-d543a50f480a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoTis® Facet Fusion Instruments
• Version Model Number: 02-9100-001
• Catalog Number: 02-9100-001
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981321826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243659

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

Devices Manufactured by Seaspine Orthopedics Corporation

• 10889981244903 - Mariner Deformity: 2025-06-23 Head Adjuster, Dual Sided
• 10889981259860 - NorthStar: 2025-06-23 4.5/5.5mm Adjustable Drill Guide
• 10889981260194 - Reef TO: 2025-06-23 Handle Extension
• 10889981326029 - Explorer TO: 2025-06-23 Bone Delivery Rack Plunger
• 10889981337797 - Specials: 2025-06-23 Dilator 2.5, Light Port
• 10889981383183 - Specials: 2025-06-23 1/4" SQ Torque Limiting Adaptor, 20 in-lbs
• 10889981425388 - Specials: 2025-06-23 Osteophyte Biter
• 10889981426972 - Specials: 2025-06-23 Trial Drill Guide, 6 mm