Stern Fix Sternal Stabilization System
FDA 510(k) clearance K211613 · decided 2022-01-19
Clearance details
- K-number
- K211613
- Device name
- Stern Fix Sternal Stabilization System
- Applicant
- Neos Surgery S.L
- Decision
- Substantially Equivalent
- Date received
- 2021-05-26
- Decision date
- 2022-01-19
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- JDQ
- Device class
- 2
- Regulation number
- 888.3010
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cable-Ready® Cable Grip System (K261271) | Pioneer Surgical Technology, Inc. | 2026-07-16 |
| Stitch Cerclage – Suture Tapes (K243905) | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 |
| Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (K243344) | Arthrex, Inc. | 2025-02-20 |
| Mbrace Cable (K232733) | Medacta International S.A. | 2024-05-03 |
| ACCORD Cable System (K233949) | Smith & Nephew, Inc. | 2024-03-13 |
| VariTrax Sternal CircumFixation System (K232986) | Circumfix Solutions, Inc. | 2024-01-30 |
| Arthrex Radiopaque FiberTape Cerclage sutures (K230976) | Arthrex, Inc. | 2023-08-24 |
| STRETTO™ Cable System (K231333) | Globus Medical, Inc. | 2023-08-04 |
| HS Fiber Cerclage (K220765) | Riverpoint Medical, LLC | 2023-07-26 |
| STERN FIX Sternal Stabilization System (K221795) | Neos Surgery S.L | 2022-10-19 |
| EVOS Cabling System (K201497) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 |
| Dall-Miles® Cable System (K202016) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 |
Recalls involving this device
No recalls on record reference this clearance.