The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Independence Spacer.
| Device ID | K120101 |
| 510k Number | K120101 |
| Device Name: | INDEPENDENCE SPACER |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Meriam Youssef |
| Correspondent | Meriam Youssef GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-12 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095306415 | K120101 | 000 |
| 00889095258431 | K120101 | 000 |
| 00889095258424 | K120101 | 000 |
| 00889095258417 | K120101 | 000 |
| 00889095258400 | K120101 | 000 |
| 00889095258394 | K120101 | 000 |
| 00889095258387 | K120101 | 000 |
| 00889095258370 | K120101 | 000 |
| 00889095048032 | K120101 | 000 |
| 00889095048025 | K120101 | 000 |
| 00889095047967 | K120101 | 000 |
| 00889095047943 | K120101 | 000 |
| 00889095047936 | K120101 | 000 |
| 00889095258448 | K120101 | 000 |
| 00889095258455 | K120101 | 000 |
| 00889095306408 | K120101 | 000 |
| 00889095306392 | K120101 | 000 |
| 00889095306385 | K120101 | 000 |
| 00889095306378 | K120101 | 000 |
| 00889095306361 | K120101 | 000 |
| 00889095306354 | K120101 | 000 |
| 00889095306347 | K120101 | 000 |
| 00889095258509 | K120101 | 000 |
| 00889095258493 | K120101 | 000 |
| 00889095258486 | K120101 | 000 |
| 00889095258479 | K120101 | 000 |
| 00889095258462 | K120101 | 000 |
| 00889095047875 | K120101 | 000 |