CoFix System
FDA 510(k) K201704 · Paradigm Spine GmbH
510(k) numberK201704
Submission
- Device name
- CoFix System
- Applicant
- Paradigm Spine GmbH
Marquette, MI, US - Received
- June 22, 2020
- Decision date
- August 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
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| K120491 | DSS Stabilization System-RigidMNH · Traditional | 05/09/2012SESU |
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| K093438 | Paradigm Interspinous Fusion PlateKWP · Traditional | 10/06/2010SE |
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Questions and answers
When was CoFix System cleared by the FDA?
CoFix System (K201704) received a 510(k) decision of Substantially Equivalent on August 4, 2020, 43 days after the submission was received.
What is the product code of K201704?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.