Cortical Fixation Systems
FDA 510(k) K181086 · Cousin Biotech Sas
510(k) numberK181086
Submission
- Device name
- Cortical Fixation Systems
- Applicant
- Cousin Biotech Sas
Wervicq-Sud, FR - Received
- April 25, 2018
- Decision date
- January 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K181799 | ResCUBE Ligament Fixation SystemOWI · Traditional | 08/29/2018SE |
| K172206 | NAJA Ligament Correction SystemOWI · Traditional | 04/10/2018SE |
| K133889 | PremiumFTL · Traditional | 09/04/2014SE |
| K093196 | Biomesh Ca.B.S. 'Air Composite, Models: CABST1R05T, CABSAIRC7, CABSAIRC09FTL · Abbreviated | 06/25/2010SE |
| K072962 | Cabs'AirFTL · Traditional | 06/26/2008SE |
| K070918 | 4DDOMEFTL · Traditional | 08/22/2007SE |
Questions and answers
When was Cortical Fixation Systems cleared by the FDA?
Cortical Fixation Systems (K181086) received a 510(k) decision of Substantially Equivalent on January 9, 2019, 259 days after the submission was received.
What is the product code of K181086?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.