Metagen Activelock Wire Cerclage System
FDA 510(k) K983976 · Metagen, LLC
510(k) numberK983976
Submission
- Device name
- Metagen Activelock Wire Cerclage System
- Applicant
- Metagen, LLC
Menomonie, WI, US - Received
- November 9, 1998
- Decision date
- December 30, 1998
- 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 |
| 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 |
|---|---|---|
| K980609 | Segmental Defect Replacement SystemHSB · Traditional | 05/18/1998SE |
| K980020 | Activelock Modular Femoral Hip SystemLPH · Traditional | 04/03/1998SN |
| K964003 | Metagen All Poly Acetabular Cup SystemJDI · Traditional | 03/21/1997SE |
| K963700 | Metagen High Tibial Osteotomy SystemHRS · Traditional | 02/12/1997SE |
Questions and answers
When was Metagen Activelock Wire Cerclage System cleared by the FDA?
Metagen Activelock Wire Cerclage System (K983976) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 51 days after the submission was received.
What is the product code of K983976?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.