12MM and 13MM Tibial Nails
FDA 510(k) K130625 · Advanced Orthopaedic Solutions, Inc.
510(k) numberK130625
Submission
- Device name
- 12MM and 13MM Tibial Nails
- Applicant
- Advanced Orthopaedic Solutions, Inc.
Torrance, CA, US - Received
- March 8, 2013
- Decision date
- March 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating SystemHRS · Traditional | 10/26/2020SE |
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | 08/28/2020SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | 07/18/2019SE |
| K182466 | AOS Calcaneal Plating SystemHRS · Traditional | 10/30/2018SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | 03/15/2016SE |
| K143204 | AOS Clavicle Intramedullary DeviceHSB · Traditional | 06/03/2015SE |
| K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…KTT · Traditional | 10/29/2014SE |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional | 07/08/2014SE |
| K133081 | Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special | 12/31/2013SE |
| K132005 | Retrograde Femoral NailHSB · Traditional | 09/10/2013SE |
Questions and answers
When was 12MM and 13MM Tibial Nails cleared by the FDA?
12MM and 13MM Tibial Nails (K130625) received a 510(k) decision of Substantially Equivalent on March 28, 2013, 20 days after the submission was received.
What is the product code of K130625?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.