LigaPASS
Bone Fixation Cerclage, Sublaminar
Medicrea International S.A.
The following data is part of a premarket notification filed by Medicrea International S.a. with the FDA for Ligapass.
Pre-market Notification Details
| Device ID | K172021 |
| 510k Number | K172021 |
| Device Name: | LigaPASS |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | Medicrea International S.A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140 |
| Contact | David Ryan |
| Correspondent | David Ryan Medicrea International S.A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-08-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720271246 | K172021 | 000 |
| 03613720271253 | K172021 | 000 |
| 03613720271239 | K172021 | 000 |
| 03613720271222 | K172021 | 000 |
Trademark Results [LigaPASS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIGAPASS 79105527 4239786 Live/Registered |
MEDICREA INTERNATIONAL 2011-09-26 |
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