Emerge Medical Im Nail System
FDA 510(k) K141347 · Emerge Medical
510(k) numberK141347
Submission
- Device name
- Emerge Medical Im Nail System
- Applicant
- Emerge Medical
Denver, CO, US - Received
- May 22, 2014
- Decision date
- October 2, 2014
- 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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|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K140675 | Emerge External Fixation SystemKTT · Traditional | 06/10/2014SE |
| K140107 | Emerge Medical Distal Radius SetHRS · Traditional | 03/13/2014SE |
| K140119 | Emerge Medical Periarticular and Locking Large Fragment SystemHRS · Traditional | 03/12/2014SE |
| K140098 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 03/12/2014SE |
| K133536 | Emerge Medical Bone Plate SystemHRS · Traditional | 02/26/2014SE |
| K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate SystemHRS · Traditional | 01/28/2014SE |
| K133452 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 01/08/2014SE |
| K131480 | Emerge Medical Locking One-Third Tubular Plate SystemHRS · Traditional | 07/03/2013SE |
| K122489 | Emerge Medical Solid Bone ScrewsHWC · Traditional | 12/10/2012SE |
| K102343 | Emerge Medical Cannulated Screw Fixation SystemHWC · Traditional | 11/23/2010SE |
Questions and answers
When was Emerge Medical Im Nail System cleared by the FDA?
Emerge Medical Im Nail System (K141347) received a 510(k) decision of Substantially Equivalent on October 2, 2014, 133 days after the submission was received.
What is the product code of K141347?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.