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PROMETHEAN RESTORATIVE

US

Last updated September 17, 2026

What PROMETHEAN RESTORATIVE makes

The company manufactures orthopaedic implants and surgical instruments for spinal and sacroiliac joint procedures, including uncoated sacroiliac joint fixation devices, non-bioabsorbable spinal bone screws, and reusable positioning instruments for orthopaedic prostheses. Their portfolio also includes spinal guidewires, bone taps, instrument trays, surgical handles, and implant drivers designed for spinal and joint arthrodesis applications.

These devices are classified under FDA categories Class I and Class II and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
333 Perry St Ste 210, Castle Rock, CO, 80104
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3030400539
DUNS Number
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Catalogue (205)

Page 5 of 5
DeviceModel / ReferenceRegistriesClassStatus
FUSIO SI Allograft System BI0018
FDA UDI
Class IActive
FUSIO SI Allograft System BI0012
FDA UDI
Class IActive
DYNAMIS™ Navigation System K252962
FDA 510(k)
Class IIActive
DYNAMIS™ Implant System K251075
FDA 510(k)
Class IIActive
DYNAMIS™ SI Screw System K243565
FDA 510(k)
Class IIActive

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