The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Monument Spacers.
| Device ID | K132559 |
| 510k Number | K132559 |
| Device Name: | MONUMENT SPACERS |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula 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 | 2013-08-15 |
| Decision Date | 2013-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095170993 | K132559 | 000 |
| 00889095085242 | K132559 | 000 |
| 00889095085211 | K132559 | 000 |
| 00889095085204 | K132559 | 000 |
| 00889095085198 | K132559 | 000 |
| 00889095085181 | K132559 | 000 |
| 00889095085150 | K132559 | 000 |
| 00889095085143 | K132559 | 000 |
| 00889095085136 | K132559 | 000 |
| 00889095085129 | K132559 | 000 |
| 00889095085099 | K132559 | 000 |
| 00889095085082 | K132559 | 000 |
| 00889095085075 | K132559 | 000 |
| 00889095085259 | K132559 | 000 |
| 00889095085266 | K132559 | 000 |
| 00889095085273 | K132559 | 000 |
| 00889095170986 | K132559 | 000 |
| 00889095170849 | K132559 | 000 |
| 00889095170832 | K132559 | 000 |
| 00889095170665 | K132559 | 000 |
| 00889095170658 | K132559 | 000 |
| 00889095085389 | K132559 | 000 |
| 00889095085372 | K132559 | 000 |
| 00889095085365 | K132559 | 000 |
| 00889095085334 | K132559 | 000 |
| 00889095085327 | K132559 | 000 |
| 00889095085310 | K132559 | 000 |
| 00889095085303 | K132559 | 000 |
| 00889095085068 | K132559 | 000 |