37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE

GUDID 18257200161010

Orthofix US LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 18257200161010
• NIH Device Record Key: 33c281dc-5edd-4a52-b06a-5d8c08585a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE
• Version Model Number: 82-3713SP
• Company DUNS: 927083808
• Company Name: Orthofix US LLC
• Device Count: 1
• DM Exempt: true
• 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: 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(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)937-3199
• Email: osi-customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200161010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240749

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, 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: 2025-07-25
• Device Publish Date: 2025-07-17

Devices Manufactured by Orthofix US LLC

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• 18257200164936 - Firebird SI Navigation System: 2025-12-03 9mm DRILL, NAVIGATED
• 18257200164943 - Firebird SI Navigation System: 2025-12-03 11mm DRILL, NAVIGATED
• 18257200164950 - Firebird SI Navigation System: 2025-12-03 12mm DRILL, NAVIGATED
• 18257200165193 - Firebird SI Navigation System: 2025-12-03 MDT INLINE ADAPTER
• 18257200165223 - Firebird SI Navigation System: 2025-12-03 FIREBIRD SI NAVIGATED INTRUMENT CASE
• 18257200165124 - Firebird SI Navigation System: 2025-11-28 DRILL GUIDE
• 18257200165131 - Firebird SI Navigation System: 2025-11-28 PIN SLEEVE