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FDA 510(k)

Pantheon Proximal Femur Reconstruction (PFR) System

K-Number: K241059 · 2025-01-13

ApplicantAdler Ortho S.P.A
Decision Date2025-01-13
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon Proximal Femur Reconstruction (PFR) System is a medical device manufactured by Adler Ortho S.P.A. It received FDA 510(k) clearance on 2025-01-13 under approval number K241059. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pantheon Proximal Femur Reconstruction (PFR) System?

Pantheon Proximal Femur Reconstruction (PFR) System is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Adler Ortho S.P.A. The 510(k) number is K241059.

When was Pantheon Proximal Femur Reconstruction (PFR) System approved by the FDA?

Pantheon Proximal Femur Reconstruction (PFR) System received FDA 510(k) clearance on 2025-01-13, under approval number K241059.

What company makes Pantheon Proximal Femur Reconstruction (PFR) System?

Pantheon Proximal Femur Reconstruction (PFR) System is manufactured by Adler Ortho S.P.A.

What is the FDA product code for Pantheon Proximal Femur Reconstruction (PFR) System?

The FDA product code for Pantheon Proximal Femur Reconstruction (PFR) System is LPH.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07594639 GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP) NOT_YET_RECRUITING NCT07589309 Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation COMPLETED NCT04289480 Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms ACTIVE_NOT_RECRUITING NCT07101562 Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head RECRUITING

Related Devices (Code: LPH)

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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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