Synthes Synsonic Ulna Nail
FDA 510(k) K131984 · Synthes (Usa)
510(k) numberK131984
Submission
- Device name
- Synthes Synsonic Ulna Nail
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- June 28, 2013
- Decision date
- March 31, 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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Questions and answers
When was Synthes Synsonic Ulna Nail cleared by the FDA?
Synthes Synsonic Ulna Nail (K131984) received a 510(k) decision of Substantially Equivalent on March 31, 2014, 276 days after the submission was received.
What is the product code of K131984?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.