Ballast™ 02-8000-160

GUDID 10889981189259

Ballast, 115 x11mm

SEASPINE ORTHOPEDICS CORPORATION

Bone matrix implant, human-derived

• Primary Device ID: 10889981189259
• NIH Device Record Key: 0e67f0f3-1ecd-48f4-a8a0-c3f2b6c2b248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ballast™
• Version Model Number: 02-8000-160
• Catalog Number: 02-8000-160
• 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981189259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193040

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

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: 2023-09-06
• Device Publish Date: 2023-08-29

Devices Manufactured by SEASPINE ORTHOPEDICS CORPORATION

• 10889981174415 - Mariner Outrigger: 2024-11-07 L Con, Closed, R, 8mm, 280mm
• 10889981179700 - Mariner Outrigger: 2024-11-07 Z-Rod, Dia. 6.0mm, Co-Cr, 140mm
• 10889981197308 - NorthStar: 2024-11-07 Poly. Screw, Favored Angle 5.5mm x 34mm
• 10889981172367 - Mariner Outrigger: 2024-09-11 T-25 TAPERED INSERTER
• 10889981172381 - Mariner Outrigger: 2024-09-11 IMPLANT INSERTER, 8MM
• 10889981172398 - Mariner Outrigger: 2024-09-11 IMPLANT INSERTER, 16MM
• 10889981172404 - Mariner Outrigger: 2024-09-11 IMPLANT INSERTER, TOP LOADING
• 10889981176204 - NewPort™: 2024-09-11 Reduction Screw Inserter Sleeve, Containing