FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Cortical Fixation Systems
K Number: K181086
·
Decision Jan 9, 2019
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
6
Review Days
259
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Cortical Fixation Systems
- K Number
- K181086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cousin Biotech Sas
- Date Received
- April 25, 2018
- Decision Date
- January 9, 2019
- Product Code
- MBI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Cousin Biotech Sas
| K Number | Device Name | ||
|---|---|---|---|
| K181799 | ResCUBE Ligament Fixation System | Aug 29, 2018 | Substantially Equivalent |
| K172206 | NAJA Ligament Correction System | Apr 10, 2018 | Substantially Equivalent |
| K133889 | PREMIUM | Sep 4, 2014 | Substantially Equivalent |
| K093196 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 | Jun 25, 2010 | Substantially Equivalent |
| K072962 | CABS'AIR | Jun 26, 2008 | Substantially Equivalent |