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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 a medical device manufactured by Gpc Medical Limited. It received FDA 510(k) clearance on 2022-02-10 under approval 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. It is manufactured by Gpc Medical Limited. The 510(k) number is K203811.

When was GPC Intraheal Intramedullary Nailing System approved by the FDA?

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

What company makes GPC Intraheal Intramedullary Nailing System?

GPC Intraheal Intramedullary Nailing System is manufactured by Gpc Medical Limited.

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

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

Related Clinical Trials

NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED

Other Devices by Gpc Medical Limited

K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System 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, Stardrive

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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