Stern Fix Sternal Stabilization System
FDA 510(k) K211613 · Neos Surgery S.L
510(k) numberK211613
Submission
- Device name
- Stern Fix Sternal Stabilization System
- Applicant
- Neos Surgery S.L
Barcelona, ES - Received
- May 26, 2021
- Decision date
- January 19, 2022
- 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
Other 510(k)s with product code JDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | 02/16/2024SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | 10/19/2022SE |
| K160739 | Cranial COVERGXR · Traditional | 06/12/2016SE |
| K132044 | Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemGXR · Traditional | 09/30/2013SE |
| K101235 | Cranial Loop Cranial Bone Fixation SystemGXR · Traditional | 10/25/2010SE |
Questions and answers
When was Stern Fix Sternal Stabilization System cleared by the FDA?
Stern Fix Sternal Stabilization System (K211613) received a 510(k) decision of Substantially Equivalent on January 19, 2022, 238 days after the submission was received.
What is the product code of K211613?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.