SDB Cerclage System
FDA 510(k) K992616 · Pioneer Surgical Technology
510(k) numberK992616
Submission
- Device name
- SDB Cerclage System
- Applicant
- Pioneer Surgical Technology
Marquette, MI, US - Received
- August 4, 1999
- Decision date
- October 27, 1999
- 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 |
|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | 07/16/2026SE |
| K251436 | Resolve Anterior Cervical Plate SystemKWQ · Abbreviated | 07/11/2025SE |
| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | 11/18/2022SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | 06/23/2021SE |
| K192396 | Streamline MIS Spinal Fixation SystemNKB · Traditional | 11/26/2019SE |
| K140696 | Streamline TL Spinal Fixation SystemNKB · Special | 04/10/2014SE |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticMAX · Traditional | 03/27/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
| K132050 | NB3D Bone Void FillerMQV · Traditional | 02/07/2014SE |
| K133785 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 01/27/2014SE |
Questions and answers
When was SDB Cerclage System cleared by the FDA?
SDB Cerclage System (K992616) received a 510(k) decision of Substantially Equivalent on October 27, 1999, 84 days after the submission was received.
What is the product code of K992616?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.