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
• 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

• 00889981124017 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x6mm, 7 Degree, Sterile
• 00889981124024 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x7mm, 7 Degree, Sterile
• 00889981124031 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x8mm, 7 Degree, Sterile
• 00889981124048 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x9mm, 7 Degree, Sterile
• 00889981124055 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x10mm, 7 Degree, Sterile
• 00889981124062 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x11mm, 7 Degree, Sterile
• 00889981124079 - Shoreline ACS: 2024-12-30 No Profile Spacer, 16x14x12mm, 7 Degree, Sterile
• 00889981124086 - Shoreline ACS: 2024-12-30 No Profile Spacer, 18x15x6mm, 7 Degree, Sterile