Orthomet Wire for Suture, Cerclage
FDA 510(k) K874919 · Orthomet, Inc.
510(k) numberK874919
Submission
- Device name
- Orthomet Wire for Suture, Cerclage
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- December 3, 1987
- Decision date
- January 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K936310 | Orthomet HMC Femoral Stem ComponentLPH · Traditional | 06/07/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | 05/30/1995SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | 04/26/1995SE |
| K944752 | Orthomet Resurfacing Femoral ComponentKXA · Traditional | 12/28/1994SE |
| K930771 | Perfecta Total Hip System Coated Cocr Femoral StemJDI · Traditional | 11/30/1994SN |
| K926334 | Axiom Total Knee Syst/Acl Retain Tibial Tray/InserJWH · Traditional | 10/18/1994SN |
| K932677 | Axiom Total Knee SystemJWH · Traditional | 10/14/1994SE |
| K931678 | Orthomet LHMC Femoral StemHMC · Traditional | 10/14/1994SE |
| K931333 | Orthomet Acetabular Cup SystemLPH · Traditional | 10/14/1994SE |
| K925536 | Hybrid Femoral Stem, Perfecta Total Hip SystemKWY · Traditional | 01/07/1994SN |
Questions and answers
When was Orthomet Wire for Suture, Cerclage cleared by the FDA?
Orthomet Wire for Suture, Cerclage (K874919) received a 510(k) decision of Substantially Equivalent on January 7, 1988, 35 days after the submission was received.
What is the product code of K874919?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.