Reef TO TO1-128144

GUDID 10889981190187

Interbody, 11mm x 28mm x 14mm, 5 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 10889981190187
• NIH Device Record Key: f5c7f1d1-9869-44ed-9051-616786e32cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reef TO
• Version Model Number: TO1-128144
• Catalog Number: TO1-128144
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981190187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192132

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

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: 2020-03-03
• Device Publish Date: 2020-02-24

On-Brand Devices [Reef TO]

• 10889981213107: T-Handle, Stainless Steel
• 10889981210786: Caddy, 11mm x 28mm Trials
• 10889981210779: Caddy, 9mm x 28mm Trials
• 10889981210755: Caddy, 9mm x 24mm Trials
• 10889981210731: TLIF-O Tray Level 2
• 10889981210724: TLIF-O Tray Level 1
• 10889981210717: TLIF-O Tray Case
• 10889981206369: Trial, 9mm x 28mm x 7mm, 5 Deg
• 10889981206352: Trial, 9mm x 24mm x 7mm, 5 Deg
• 10889981206345: Trial, 11mm x 28mm x 7mm, 5 Deg
• 10889981206109: Trial, 9mm x 28mm x 18mm, 15 Deg
• 10889981206093: Trial, 9mm x 28mm x 18mm, 5 Deg
• 10889981206086: Trial, 9mm x 28mm x 18mm, 10 Deg
• 10889981206062: Trial, 9mm x 28mm x 17mm, 15 Deg
• 10889981206055: Trial, 9mm x 28mm x 17mm, 5 Deg
• 10889981206048: Trial, 9mm x 28mm x 17mm, 10 Deg
• 10889981206024: Trial, 9mm x 28mm x 16mm, 15 Deg
• 10889981206017: Trial, 9mm x 28mm x 16mm, 5 Deg
• 10889981206000: Trial, 9mm x 28mm x 16mm, 10 Deg
• 10889981205980: Trial, 9mm x 28mm x 15mm, 15 Deg
• 10889981205973: Trial, 9mm x 28mm x 15mm, 5 Deg
• 10889981205966: Trial, 9mm x 28mm x 15mm, 10 Deg
• 10889981205942: Trial, 9mm x 28mm x 14mm, 15 Deg
• 10889981205935: Trial, 9mm x 28mm x 14mm, 5 Deg
• 10889981205928: Trial, 9mm x 28mm x 14mm, 10 Deg
• 10889981205904: Trial, 9mm x 28mm x 13mm, 15 Deg
• 10889981205898: Trial, 9mm x 28mm x 13mm, 5 Deg
• 10889981205881: Trial, 9mm x 28mm x 13mm, 10 Deg
• 10889981205867: Trial, 9mm x 28mm x 12mm, 15 Deg
• 10889981205850: Trial, 9mm x 28mm x 12mm, 5 Deg
• 10889981205843: Trial, 9mm x 28mm x 12mm, 10 Deg
• 10889981205829: Trial, 9mm x 28mm x 11mm, 15 Deg
• 10889981205812: Trial, 9mm x 28mm x 11mm, 5 Deg
• 10889981205805: Trial, 9mm x 28mm x 11mm, 10 Deg
• 10889981205782: Trial, 9mm x 28mm x 10mm, 15 Deg
• 10889981205775: Trial, 9mm x 28mm x 10mm, 5 Deg
• 10889981205768: Trial, 9mm x 28mm x 10mm, 10 Deg
• 10889981205744: Trial, 9mm x 28mm x 9mm, 5 Deg
• 10889981205737: Trial, 9mm x 28mm x 9mm, 10 Deg
• 10889981205713: Trial, 9mm x 28mm x 8mm, 5 Deg
• 10889981205683: Trial, 9mm x 24mm x 18mm, 15 Deg
• 10889981205676: Trial, 9mm x 24mm x 18mm, 5 Deg
• 10889981205669: Trial, 9mm x 24mm x 18mm, 10 Deg
• 10889981205645: Trial, 9mm x 24mm x 17mm, 15 Deg
• 10889981205638: Trial, 9mm x 24mm x 17mm, 5 Deg
• 10889981205621: Trial, 9mm x 24mm x 17mm, 10 Deg
• 10889981205607: Trial, 9mm x 24mm x 16mm, 15 Deg
• 10889981205591: Trial, 9mm x 24mm x 16mm, 5 Deg
• 10889981205584: Trial, 9mm x 24mm x 16mm, 10 Deg
• 10889981205560: Trial, 9mm x 24mm x 15mm, 15 Deg