Jazz System
FDA 510(k) K121541 · Implanet, S.A.
510(k) numberK121541
Submission
- Device name
- Jazz System
- Applicant
- Implanet, S.A.
Philedelphia, PA, US - Received
- May 24, 2012
- Decision date
- September 13, 2012
- 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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| 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 |
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| 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 |
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| K192084 | Madison Total Knee SystemJWH · Traditional | 10/22/2019SE |
| K191217 | Jazz PFOWI · Traditional | 08/02/2019SE |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SPNKB · Traditional | 03/12/2019SE |
| K171881 | JAZZ Passer BandOWI · Traditional | 08/08/2017SE |
| K170730 | JAZZ System, including JAZZ BandOWI · Traditional | 06/09/2017SE |
| K162764 | Jazz Frame SystemNKB · Traditional | 01/19/2017SE |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorNKB · Traditional | 05/18/2016SE |
| K153348 | Jazz LockOWI · Traditional | 03/31/2016SE |
| K151740 | JAZZ SystemOWI · Traditional | 08/27/2015SE |
Questions and answers
When was Jazz System cleared by the FDA?
Jazz System (K121541) received a 510(k) decision of Substantially Equivalent on September 13, 2012, 112 days after the submission was received.
What is the product code of K121541?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.