The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Elsa Spacers.
| Device ID | K161379 |
| 510k Number | K161379 |
| Device Name: | ELSA Spacers |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-18 |
| Decision Date | 2016-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095334524 | K161379 | 000 |
| 00889095258073 | K161379 | 000 |
| 00889095258066 | K161379 | 000 |
| 00889095258042 | K161379 | 000 |
| 00889095258035 | K161379 | 000 |
| 00889095258028 | K161379 | 000 |
| 00889095258011 | K161379 | 000 |
| 00889095258004 | K161379 | 000 |
| 00889095257991 | K161379 | 000 |
| 00889095257977 | K161379 | 000 |
| 00889095257960 | K161379 | 000 |
| 00889095257953 | K161379 | 000 |
| 00889095257946 | K161379 | 000 |
| 00889095257939 | K161379 | 000 |
| 00889095258080 | K161379 | 000 |
| 00889095258097 | K161379 | 000 |
| 00889095334517 | K161379 | 000 |
| 00889095334500 | K161379 | 000 |
| 00889095334494 | K161379 | 000 |
| 00889095334487 | K161379 | 000 |
| 00889095334470 | K161379 | 000 |
| 00889095334456 | K161379 | 000 |
| 00889095334449 | K161379 | 000 |
| 00889095334432 | K161379 | 000 |
| 00889095334425 | K161379 | 000 |
| 00889095334418 | K161379 | 000 |
| 00889095334401 | K161379 | 000 |
| 00889095258110 | K161379 | 000 |
| 00889095258103 | K161379 | 000 |
| 00889095257922 | K161379 | 000 |