Identifiers
- 510(k) Number
- K251075 FDA 510(k)
- FDA Product Code
- OUR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dynamis Implant System is an orthopedic implant system intended for spinal and sacroiliac joint stabilization. It is designed to provide structural support and promote fusion of the targeted vertebral or joint segments.
The system is marketed by Promethean Restorative LLC, located at 333 Perry St., Suite 210, Castle Rock, CO 80104, United States. It has received FDA 510(k) clearance (K251075) under a special clearance pathway and is classified as substantially equivalent to a predicate device (product code OUR).
Frequently asked questions
What is the Dynamis Implant System intended for?
The Dynamis Implant System is intended for spinal and sacroiliac joint stabilization, providing structural support and promoting fusion of the targeted vertebral or joint segments as an orthopedic implant system.
Who manufactures the Dynamis Implant System and where are they located?
The Dynamis Implant System is manufactured by Promethean Restorative LLC, located at 333 Perry St., Suite 210, Castle Rock, CO 80104, United States.
What regulatory clearance does the Dynamis Implant System have?
The Dynamis Implant System has received FDA 510(k) clearance under the special clearance pathway, with clearance number K251075, and is classified as substantially equivalent to a predicate device under product code OUR.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Promethean Restorative LLC - DYNAMIS™ Implant System, DYNAMIS™ Implant System IFU - Promethean Restorative Inc., Promethean Restorative, LLC FDA 510(k) Products - Latest 2026, PDF Promethean Restorative LLC Glenn Bowman 333 Perry Street, Suite 210 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251075 | Class II | Active |
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Manufacturer
- Manufacturer
- Promethean Restorative Llc
- FDA Applicant
- Promethean Restorative, LLC
Sources (1)
- FDA 510(k) K251075 24 fields · synced Oct 1, 2026