Osteo Cerclage Wire
FDA 510(k) K914374 · Osteo AG
510(k) numberK914374
Submission
- Device name
- Osteo Cerclage Wire
- Applicant
- Osteo AG
Greenwood, SC, US - Received
- October 1, 1991
- Decision date
- December 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
|---|---|---|
| K933340 | Osteo Interlocking-Compression NailHSB · Traditional | 06/30/1994SE |
| K922196 | Osteo Tibia NailHSB · Traditional | 07/23/1992SE |
| K922195 | Osteo Femoral NailHSB · Traditional | 07/23/1992SE |
| K922194 | Osteo Steinmann PinHTY · Traditional | 07/23/1992SE |
| K922193 | Osteo Kirschner WireHTY · Traditional | 07/23/1992SE |
| K920149 | Osteo Ex-Fi-ReJEC · Traditional | 04/09/1992SE |
| K920037 | Osteo Compression Hip ScrewHRC · Traditional | 03/11/1992SE |
| K913559 | Osteo Complete Pneumatic Drill-OscilairHSZ · Traditional | 11/07/1991SE |
Questions and answers
When was Osteo Cerclage Wire cleared by the FDA?
Osteo Cerclage Wire (K914374) received a 510(k) decision of Substantially Equivalent on December 30, 1991, 90 days after the submission was received.
What is the product code of K914374?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.