Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

K-Number: K253080 · 2026-06-18

ApplicantSuzhou and Science & Technology Development Corp.
Decision Date2026-06-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou and Science & Technology Development Corp.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253080. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Suzhou and Science & Technology Development Corp.. The 510(k) number is K253080.

When did AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) receive FDA 510(k) clearance?

AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253080.

Who is the listed applicant for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

The FDA 510(k) record lists Suzhou and Science & Technology Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)?

The FDA product code for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) is HSB.

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix SrlK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl

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.

↑