The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Microfuse Putty And Microfuse St Mis.
| Device ID | K102392 |
| 510k Number | K102392 |
| Device Name: | MICROFUSE PUTTY AND MICROFUSE ST MIS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly J Baker Ph.d. |
| Correspondent | Kelly J Baker Ph.d. 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 | 2010-08-23 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044044263 | K102392 | 000 |
| 00849044044256 | K102392 | 000 |
| 00849044044249 | K102392 | 000 |
| 00849044044157 | K102392 | 000 |
| 00849044044140 | K102392 | 000 |
| 00849044044133 | K102392 | 000 |
| 00849044044126 | K102392 | 000 |