Compressyn Band
FDA 510(k) K101484 · Dallen Medical
510(k) numberK101484
Submission
- Device name
- Compressyn Band
- Applicant
- Dallen Medical
San Clemente, CA, US - Received
- May 28, 2010
- Decision date
- April 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
More from Neos Surgery S.L
| 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 |
| K131850 | Tensyn BandHTN · Traditional | 11/15/2013SE |
| K130431 | Compressyn BandJDQ · Traditional | 07/25/2013SE |
| K122871 | Compressyn StapleJDR · Traditional | 02/07/2013SE |
Questions and answers
When was Compressyn Band cleared by the FDA?
Compressyn Band (K101484) received a 510(k) decision of Substantially Equivalent on April 1, 2011, 308 days after the submission was received.
What is the product code of K101484?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.