NAJA Ligament Correction System
FDA 510(k) K172206 · Cousin Biotech Sas
510(k) numberK172206
Submission
- Device name
- NAJA Ligament Correction System
- Applicant
- Cousin Biotech Sas
Wervicq-Sud, FR - Received
- July 21, 2017
- Decision date
- April 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWI – Bone Fixation Cerclage, Sublaminar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
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| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
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More from Implanet, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K181086 | Cortical Fixation SystemsMBI · Traditional | 01/09/2019SE |
| K181799 | ResCUBE Ligament Fixation SystemOWI · Traditional | 08/29/2018SE |
| 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 NAJA Ligament Correction System cleared by the FDA?
NAJA Ligament Correction System (K172206) received a 510(k) decision of Substantially Equivalent on April 10, 2018, 263 days after the submission was received.
What is the product code of K172206?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.