The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Altera Spacer.
| Device ID | K140411 |
| 510k Number | K140411 |
| Device Name: | ALTERA 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 | 2014-02-18 |
| Decision Date | 2014-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095174595 | K140411 | 000 |
| 00889095069778 | K140411 | 000 |
| 00889095069754 | K140411 | 000 |
| 00889095069747 | K140411 | 000 |
| 00889095069716 | K140411 | 000 |
| 00889095069693 | K140411 | 000 |
| 00889095069686 | K140411 | 000 |
| 00889095069679 | K140411 | 000 |
| 00889095069570 | K140411 | 000 |
| 00889095069556 | K140411 | 000 |
| 00889095069549 | K140411 | 000 |
| 00889095069518 | K140411 | 000 |
| 00889095069877 | K140411 | 000 |
| 00889095069884 | K140411 | 000 |
| 00889095174571 | K140411 | 000 |
| 00889095174564 | K140411 | 000 |
| 00889095174557 | K140411 | 000 |
| 00889095174540 | K140411 | 000 |
| 00889095258363 | K140411 | 000 |
| 00889095258356 | K140411 | 000 |
| 00889095069976 | K140411 | 000 |
| 00889095069952 | K140411 | 000 |
| 00889095069945 | K140411 | 000 |
| 00889095069914 | K140411 | 000 |
| 00889095069891 | K140411 | 000 |
| 00889095069495 | K140411 | 000 |