GPC Intramedullary Nailing Systems
FDA 510(k) K143245 · Gpc Medical Limited
510(k) numberK143245
Submission
- Device name
- GPC Intramedullary Nailing Systems
- Applicant
- Gpc Medical Limited
New Delhi, IN - Received
- November 12, 2014
- Decision date
- September 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
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|---|---|---|
| K203811 | GPC Intraheal Intramedullary Nailing SystemHSB · Traditional | 02/10/2022SE |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…HRS · Traditional | 01/07/2022SE |
| K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemNKB · Traditional | 03/31/2017SE |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.HRS · Traditional | 05/17/2016SE |
| K092493 | GPC Bone Plaes and Bone Screw & GPC Dhs/Dcs Plate SystemHRS · Traditional | 03/29/2010SE |
Questions and answers
When was GPC Intramedullary Nailing Systems cleared by the FDA?
GPC Intramedullary Nailing Systems (K143245) received a 510(k) decision of Substantially Equivalent on September 30, 2015, 322 days after the submission was received.
What is the product code of K143245?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.