SpF®-PLUS-Mini (60 uA/M) 10-1398M

GUDID 00812301020126

SPF-PLUS 60/M Implantable Spinal Fusion Stimulator

EBI, LLC

Patient-worn bone growth electromagnetic stimulator

• Primary Device ID: 00812301020126
• NIH Device Record Key: 409e3440-afc5-4742-8612-8f26be5e9b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpF®-PLUS-Mini (60 uA/M)
• Version Model Number: 10-1398M
• Catalog Number: 10-1398M
• Company DUNS: 050410323
• Company Name: EBI, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com
• Phone: 1.973.299.9300
• Email: btbs.csorders@biomet.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812301020126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850035

FDA Product Code

• LOE: Stimulator, Invasive Bone Growth

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: 2018-07-06
• Device Publish Date: 2014-09-19

Devices Manufactured by EBI, LLC

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• 00887868269271 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System: 2019-03-11
• 00887868269288 - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System: 2019-03-11
• 00887868269295 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00887868269301 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00887868269318 - Biomet OrthoPak Non-invasive Bone Growth Stimulator System: 2019-03-11
• 00880304820845 - Biomet SpinalPak / OrthoPak: 2018-07-06 BELT EXTENSION, LARGE, SPINALPAK
• 00880304820852 - Biomet SpinalPak / OrthoPak: 2018-07-06 ELECTRODES, 63B, SPINALPAK/ORTHOPAK