FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ResCUBE Ligament Fixation System
K Number: K181799
·
Decision Aug 29, 2018
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
6
Review Days
55
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Basic Information
- Device Name
- ResCUBE Ligament Fixation System
- K Number
- K181799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cousin Biotech Sas
- Date Received
- July 5, 2018
- Decision Date
- August 29, 2018
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
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Other Clearances by Cousin Biotech Sas
| K Number | Device Name | ||
|---|---|---|---|
| K181086 | Cortical Fixation Systems | Jan 9, 2019 | 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 |