Osteo-Clage(Tm) Cerciage Cable System
FDA 510(k) K921480 · Acu-Med, Inc.
510(k) numberK921480
Submission
- Device name
- Osteo-Clage(Tm) Cerciage Cable System
- Applicant
- Acu-Med, Inc.
Beaveton, OR, US - Received
- March 30, 1992
- Decision date
- June 26, 1992
- 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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|---|---|---|---|
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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 |
|---|---|---|
| K021321 | Wrist Fusion PlateHRS · Traditional | 07/17/2002SE |
| K013616 | Polarus Cap ScrewHSB · Traditional | 12/19/2001SE |
| K012655 | Congruent Bone Plate SystemHRS · Traditional | 11/07/2001SE |
| K992525 | Acumed Modular Shoulder SystemHSD · Traditional | 02/04/2000SE |
| K993657 | Acumed Suture AnchorMBI · Traditional | 01/13/2000SE |
| K980103 | Acumed Suture AnchorMBI · Traditional | 03/16/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | 03/17/1997SE |
| K965029 | Stableloc II External FixatorJEC · Traditional | 02/19/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
| K963026 | TBDHSB · Traditional | 10/28/1996SE |
Questions and answers
When was Osteo-Clage(Tm) Cerciage Cable System cleared by the FDA?
Osteo-Clage(Tm) Cerciage Cable System (K921480) received a 510(k) decision of Substantially Equivalent on June 26, 1992, 88 days after the submission was received.
What is the product code of K921480?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.