The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Microfuse Bone Void Filler.
| Device ID | K071187 |
| 510k Number | K071187 |
| Device Name: | MICROFUSE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER 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 | 2007-04-30 |
| Decision Date | 2007-12-20 |
| Summary: | summary |