The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Signify Bioactive.
| Device ID | K130977 |
| 510k Number | K130977 |
| Device Name: | SIGNIFY BIOACTIVE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Sarah Marie Fitzgerald |
| Correspondent | Sarah Marie Fitzgerald GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2013-12-24 |
| Summary: | summary |