The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Independence Mis Spacers.
| Device ID | K160597 |
| 510k Number | K160597 |
| Device Name: | INDEPENDENCE MIS Spacers |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly J. Baker |
| Correspondent | Kelly J. Baker GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-02 |
| Decision Date | 2016-08-29 |
| Summary: | summary |