The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Silc Fixation System.
| Device ID | K133482 |
| 510k Number | K133482 |
| Device Name: | SILC FIXATION SYSTEM |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095029215 | K133482 | 000 |
| 00889095029208 | K133482 | 000 |
| 00889095029192 | K133482 | 000 |