Tensyn Band
FDA 510(k) K131850 · Dallen Medical, Inc.
510(k) numberK131850
Submission
- Device name
- Tensyn Band
- Applicant
- Dallen Medical, Inc.
San Clemente, CA, US - Received
- June 21, 2013
- Decision date
- November 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K171473 | Compressyn StapleJDR · Traditional | 11/07/2017SE |
| K150359 | Tensyn PlugHTN · Traditional | 05/07/2015SE |
| K143092 | Tensyn PlugHTN · Traditional | 02/11/2015SE |
| K141264 | Tensyn Band, Tensyn Fracture PlatesHTN · Traditional | 08/21/2014SE |
| K140358 | Compressyn StapleJDR · Traditional | 06/02/2014SE |
| K133858 | Tensyn BandHTN · Traditional | 02/28/2014SE |
| K132875 | Compressyn StapleJDR · Traditional | 12/30/2013SE |
| K130431 | Compressyn BandJDQ · Traditional | 07/25/2013SE |
| K122871 | Compressyn StapleJDR · Traditional | 02/07/2013SE |
| K101484 | Compressyn BandJDQ · Traditional | 04/01/2011SE |
Questions and answers
When was Tensyn Band cleared by the FDA?
Tensyn Band (K131850) received a 510(k) decision of Substantially Equivalent on November 15, 2013, 147 days after the submission was received.
What is the product code of K131850?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.