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FDA 510(k)

DYNAMIS™ Implant System

K-Number: K251075 · 2025-04-25

ApplicantPromethean Restorative, LLC
Decision Date2025-04-25
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNAMIS™ Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Promethean Restorative, LLC. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K251075. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIS™ Implant System?

DYNAMIS™ Implant System is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Promethean Restorative, LLC. The 510(k) number is K251075.

When did DYNAMIS™ Implant System receive FDA 510(k) clearance?

DYNAMIS™ Implant System received FDA 510(k) clearance on 2025-04-25, under 510(k) number K251075.

Who is the listed applicant for DYNAMIS™ Implant System?

The FDA 510(k) record lists Promethean Restorative, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAMIS™ Implant System?

The FDA product code for DYNAMIS™ Implant System is OUR.

Other records listing Promethean Restorative, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252962DYNAMIS™ Navigation SystemK243565DYNAMIS™ SI Screw System

Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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