FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LIGAPASS
K Number: K132395
·
Decision Dec 6, 2013
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
17
Review Days
127
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Basic Information
- Device Name
- LIGAPASS
- K Number
- K132395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea International
- Date Received
- August 1, 2013
- Decision Date
- December 6, 2013
- 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 Medicrea International
| K Number | Device Name | ||
|---|---|---|---|
| K220810 | Infinity OCT System and PASS OCT Spinal System | Apr 19, 2022 | Substantially Equivalent |
| K220724 | CD Horizon Spinal System and PASS LP Spinal System | Apr 8, 2022 | Substantially Equivalent |
| K180091 | UNiD Spine Analyzer | Feb 8, 2018 | Substantially Equivalent |
| K170172 | UNiD Spine Analyzer | May 24, 2017 | Substantially Equivalent |
| K153169 | PASS OCT Patient Specific Rods | Jan 29, 2016 | Substantially Equivalent |
| K150049 | PASS LP Spinal System | Feb 10, 2015 | Substantially Equivalent |
| K140738 | PASS LP SPINAL SYSTEM | Nov 4, 2014 | Substantially Equivalent |
| K133906 | C-JAWS CERVICAL COMPRESSIVE STAPLE | Jul 24, 2014 | Substantially Equivalent |
| K132574 | PASS LP SPINAL SYSTEM | Nov 8, 2013 | Substantially Equivalent |
| K132575 | PASS LP SPINAL SYSTEM | Oct 3, 2013 | Substantially Equivalent |