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 | K160698 |
| 510k Number | K160698 |
| Device Name: | LigaPASS |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | David Ryan |
| Correspondent | David Ryan MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-14 |
| Decision Date | 2016-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720262282 | K160698 | 000 |
| 03613720248682 | K160698 | 000 |
Trademark Results [LigaPASS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIGAPASS 79105527 4239786 Live/Registered |
MEDICREA INTERNATIONAL 2011-09-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.