LIGAPASS
Bone Fixation Cerclage, Sublaminar
MEDICREA INTERNATIONAL
The following data is part of a premarket notification filed by Medicrea International with the FDA for Ligapass.
Pre-market Notification Details
| Device ID | K132395 |
| 510k Number | K132395 |
| Device Name: | LIGAPASS |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | Audrey Vion |
| Correspondent | Audrey Vion MEDICREA INTERNATIONAL 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 | 2013-08-01 |
| Decision Date | 2013-12-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720236726 | K132395 | 000 |
| 03613720000297 | K132395 | 000 |
| 03613720000303 | K132395 | 000 |
| 03613720000310 | K132395 | 000 |
| 03613720000327 | K132395 | 000 |
| 03613720000372 | K132395 | 000 |
| 03613720191902 | K132395 | 000 |
| 03613720191964 | K132395 | 000 |
| 03613720191971 | K132395 | 000 |
| 03613720191995 | K132395 | 000 |
| 03613720227267 | K132395 | 000 |
| 03613720000280 | K132395 | 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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