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FDA 510(k)

Dunamis Screw and Suture Locking System

K-Number: K250867 · 2025-08-15

ApplicantDunamis Medical, LLC
Decision Date2025-08-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dunamis Screw and Suture Locking System is a medical device manufactured by Dunamis Medical, LLC. It received FDA 510(k) clearance on 2025-08-15 under approval number K250867. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dunamis Screw and Suture Locking System?

Dunamis Screw and Suture Locking System is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by Dunamis Medical, LLC. The 510(k) number is K250867.

When was Dunamis Screw and Suture Locking System approved by the FDA?

Dunamis Screw and Suture Locking System received FDA 510(k) clearance on 2025-08-15, under approval number K250867.

What company makes Dunamis Screw and Suture Locking System?

Dunamis Screw and Suture Locking System is manufactured by Dunamis Medical, LLC.

What is the FDA product code for Dunamis Screw and Suture Locking System?

The FDA product code for Dunamis Screw and Suture Locking System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

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Official Source

View on FDA Database →

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

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