Reef TH TH1-132130

GUDID 10889981200831

Interbody, 11mm x 32mm x 13mm, 0 deg

SEASPINE ORTHOPEDICS CORPORATION

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10889981200831
• NIH Device Record Key: bbd09a7f-8f00-402e-8ebe-776a6b28881c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reef TH
• Version Model Number: TH1-132130
• Catalog Number: TH1-132130
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981200831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193636

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [Reef TH]

• 10889981217334: TH Instrument Level 2
• 10889981217327: TH Instrument Level 1
• 10889981217310: Tray Case, Double Level
• 10889981212940: Trial 9w, 18mm
• 10889981212933: Trial 9w, 17mm
• 10889981212926: Trial 9w, 16mm
• 10889981212919: Trial 9w, 15mm
• 10889981212902: Trial 9w, 14mm
• 10889981212896: Trial 9w, 13mm
• 10889981212889: Trial 9w, 12mm
• 10889981212872: Trial 9w, 11mm
• 10889981212865: Trial 9w, 10mm
• 10889981212858: Trial 9w, 9mm
• 10889981212841: Trial 9w, 8mm
• 10889981212834: Trial 11w, 18mm
• 10889981212827: Trial 11w, 17mm
• 10889981212810: Trial 11w, 16mm
• 10889981212803: Trial 11w, 15mm
• 10889981212797: Trial 11w, 14mm
• 10889981212780: Trial 11w, 13mm
• 10889981212773: Trial 11w, 12mm
• 10889981212766: Trial 11w, 11mm
• 10889981212759: Trial 11w, 10mm
• 10889981212742: Trial 11w, 9mm
• 10889981212735: Trial 11w, 8mm
• 10889981207106: Notched Tamp
• 10889981207090: Inserter, 9w
• 10889981203580: Interbody, 9mm x 40mm x 18mm, 8 deg
• 10889981203573: Interbody, 9mm x 40mm x 18mm, 15 deg
• 10889981203566: Interbody, 9mm x 40mm x 18mm, 20 deg
• 10889981203559: Interbody, 9mm x 40mm x 18mm, 0 deg
• 10889981203542: Interbody, 9mm x 40mm x 17mm, 8 deg
• 10889981203535: Interbody, 9mm x 40mm x 17mm, 15 deg
• 10889981203528: Interbody, 9mm x 40mm x 17mm, 20 deg
• 10889981203511: Interbody, 9mm x 40mm x 17mm, 0 deg
• 10889981203504: Interbody, 9mm x 40mm x 16mm, 8 deg
• 10889981203498: Interbody, 9mm x 40mm x 16mm, 15 deg
• 10889981203481: Interbody, 9mm x 40mm x 16mm, 20 deg
• 10889981203474: Interbody, 9mm x 40mm x 16mm, 0 deg
• 10889981203467: Interbody, 9mm x 40mm x 15mm, 8 deg
• 10889981203450: Interbody, 9mm x 40mm x 15mm, 15 deg
• 10889981203443: Interbody, 9mm x 40mm x 15mm, 20 deg
• 10889981203436: Interbody, 9mm x 40mm x 15mm, 0 deg
• 10889981203429: Interbody, 9mm x 40mm x 14mm, 8 deg
• 10889981203412: Interbody, 9mm x 40mm x 14mm, 15 deg
• 10889981203405: Interbody, 9mm x 40mm x 14mm, 20 deg
• 10889981203399: Interbody, 9mm x 40mm x 14mm, 0 deg
• 10889981203382: Interbody, 9mm x 40mm x 13mm, 8 deg
• 10889981203375: Interbody, 9mm x 40mm x 13mm, 15 deg
• 10889981203368: Interbody, 9mm x 40mm x 13mm, 20 deg