Synthes Trochanteric Fixation Nail - Advanced System
FDA 510(k) K131548 · Synthes (USA) Products, LLC
510(k) numberK131548
Submission
- Device name
- Synthes Trochanteric Fixation Nail - Advanced System
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- May 30, 2013
- Decision date
- February 28, 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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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
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| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
Questions and answers
When was Synthes Trochanteric Fixation Nail - Advanced System cleared by the FDA?
Synthes Trochanteric Fixation Nail - Advanced System (K131548) received a 510(k) decision of Substantially Equivalent on February 28, 2014, 274 days after the submission was received.
What is the product code of K131548?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.