FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LigaPASS 2.0 Ligament Augmentation System
K Number: K213659
·
Decision May 24, 2022
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
25
Review Days
186
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Basic Information
- Device Name
- LigaPASS 2.0 Ligament Augmentation System
- K Number
- K213659
- 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 SA
- Date Received
- November 19, 2021
- Decision Date
- May 24, 2022
- 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 SA
| K Number | Device Name | ||
|---|---|---|---|
| K213281 | PASS LP Spinal System, CD Horizon Spinal System | Jan 5, 2022 | Substantially Equivalent |
| K210470 | C-CURVE Interbody Fusion Device | Sep 3, 2021 | Substantially Equivalent |
| K200316 | UNiD IB3D ALIF | Oct 30, 2020 | Substantially Equivalent |
| K191134 | IB3D ALIF | Oct 30, 2019 | Substantially Equivalent |
| K182158 | UNiD Patient-matched PLIF cage | Jul 15, 2019 | Substantially Equivalent |
| K190092 | UNiD Patient specific 3D printed TLIF cage | May 8, 2019 | Substantially Equivalent |
| K190376 | PASS LP Spinal System | May 2, 2019 | Substantially Equivalent |
| K182240 | PASS LP Spinal System | Oct 17, 2018 | Substantially Equivalent |
| K173782 | UNiD Patient Specific 3D printed cage | Apr 25, 2018 | Substantially Equivalent |
| K173506 | LigaPASS | Apr 3, 2018 | Substantially Equivalent |