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)

SIGN PEDIATRIC FIN NAIL

K-Number: K122823 · 2013-04-16

ApplicantSign Fracture Care International
Decision Date2013-04-16
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGN PEDIATRIC FIN NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Sign Fracture Care International. It received FDA 510(k) clearance on 2013-04-16 under 510(k) number K122823. 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 SIGN PEDIATRIC FIN NAIL?

SIGN PEDIATRIC FIN NAIL is a medical device that received FDA 510(k) clearance on 2013-04-16. The listed applicant is Sign Fracture Care International. The 510(k) number is K122823.

When did SIGN PEDIATRIC FIN NAIL receive FDA 510(k) clearance?

SIGN PEDIATRIC FIN NAIL received FDA 510(k) clearance on 2013-04-16, under 510(k) number K122823.

Who is the listed applicant for SIGN PEDIATRIC FIN NAIL?

The FDA 510(k) record lists Sign Fracture Care International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGN PEDIATRIC FIN NAIL?

The FDA product code for SIGN PEDIATRIC FIN NAIL is HSB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sign Fracture Care International 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.

K163589SIGN IM NailK153759SIGN Compression Screw System

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ 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.

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.

↑