DePuy Synthes TFNA Augmentation System
FDA 510(k) K160167 · Synthes (USA) Products, LLC
510(k) numberK160167
Submission
- Device name
- DePuy Synthes TFNA Augmentation System
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- January 27, 2016
- Decision date
- September 26, 2016
- 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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Questions and answers
When was DePuy Synthes TFNA Augmentation System cleared by the FDA?
DePuy Synthes TFNA Augmentation System (K160167) received a 510(k) decision of Substantially Equivalent on September 26, 2016, 243 days after the submission was received.
What is the product code of K160167?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.