STERN FIX Sternal Stabilization System
Cerclage, Fixation
Neos Surgery SL
The following data is part of a premarket notification filed by Neos Surgery Sl with the FDA for Stern Fix Sternal Stabilization System.
Pre-market Notification Details
| Device ID | K221795 |
| 510k Number | K221795 |
| Device Name: | STERN FIX Sternal Stabilization System |
| Classification | Cerclage, Fixation |
| Applicant | Neos Surgery SL Parc Technologic Del Valles Barcelona, ES 08290 |
| Contact | Eduard Garcia Puig |
| Correspondent | Cherita James M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-10-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28437006085445 | K221795 | 000 |
| 28437006085483 | K221795 | 000 |
| 08437006085472 | K221795 | 000 |
| 28437006085469 | K221795 | 000 |
| 28437006085452 | K221795 | 000 |
Trademark Results [STERN FIX Sternal Stabilization System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERN FIX STERNAL STABILIZATION SYSTEM 79309999 not registered Live/Pending |
NEOS SURGERY, S.L. 2021-01-12 |
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