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)

GPC Intraheal Intramedullary Nailing System

K-Number: K203811 · 2022-02-10

ApplicantGpc Medical Limited
Decision Date2022-02-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPC Intraheal Intramedullary Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Gpc Medical Limited. It received FDA 510(k) clearance on 2022-02-10 under 510(k) number K203811. 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 GPC Intraheal Intramedullary Nailing System?

GPC Intraheal Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-10. The listed applicant is Gpc Medical Limited. The 510(k) number is K203811.

When did GPC Intraheal Intramedullary Nailing System receive FDA 510(k) clearance?

GPC Intraheal Intramedullary Nailing System received FDA 510(k) clearance on 2022-02-10, under 510(k) number K203811.

Who is the listed applicant for GPC Intraheal Intramedullary Nailing System?

The FDA 510(k) record lists Gpc Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPC Intraheal Intramedullary Nailing System?

The FDA product code for GPC Intraheal Intramedullary Nailing System is HSB.

Other records listing Gpc Medical Limited 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.

K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, StardriveK163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemK153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating 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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule 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 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.

↑