ACCORD Cable System
FDA 510(k) K233949 · Smith & Nephew, Inc.
510(k) numberK233949
Submission
- Device name
- ACCORD Cable System
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- December 14, 2023
- Decision date
- March 13, 2024
- 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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| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
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| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
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Questions and answers
When was ACCORD Cable System cleared by the FDA?
ACCORD Cable System (K233949) received a 510(k) decision of Substantially Equivalent on March 13, 2024, 90 days after the submission was received.
What is the product code of K233949?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.