The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Modification To:microfuse Bone Void Filler.
| Device ID | K083232 |
| 510k Number | K083232 |
| Device Name: | MODIFICATION TO:MICROFUSE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2008-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044043846 | K083232 | 000 |