The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Latis Spacer.
| Device ID | K123913 |
| 510k Number | K123913 |
| Device Name: | LATIS SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095056235 | K123913 | 000 |
| 00889095048131 | K123913 | 000 |
| 00889095048124 | K123913 | 000 |
| 00889095048117 | K123913 | 000 |
| 00889095048100 | K123913 | 000 |
| 00889095048094 | K123913 | 000 |
| 00889095048087 | K123913 | 000 |
| 00889095048070 | K123913 | 000 |
| 00889095048063 | K123913 | 000 |
| 00889095048056 | K123913 | 000 |
| 00889095048148 | K123913 | 000 |
| 00889095048155 | K123913 | 000 |
| 00889095048162 | K123913 | 000 |
| 00889095056228 | K123913 | 000 |
| 00889095056211 | K123913 | 000 |
| 00889095048230 | K123913 | 000 |
| 00889095048223 | K123913 | 000 |
| 00889095048216 | K123913 | 000 |
| 00889095048209 | K123913 | 000 |
| 00889095048193 | K123913 | 000 |
| 00889095048186 | K123913 | 000 |
| 00889095048179 | K123913 | 000 |
| 00889095048049 | K123913 | 000 |