Spinal Concepts, Inc., Cfix Cable System
FDA 510(k) K974020 · Spinal Concepts, Inc.
510(k) numberK974020
Submission
- Device name
- Spinal Concepts, Inc., Cfix Cable System
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- October 22, 1997
- Decision date
- December 19, 1997
- 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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| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
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| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
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Questions and answers
When was Spinal Concepts, Inc., Cfix Cable System cleared by the FDA?
Spinal Concepts, Inc., Cfix Cable System (K974020) received a 510(k) decision of Substantially Equivalent on December 19, 1997, 58 days after the submission was received.
What is the product code of K974020?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.