The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Coalition Spacer.
| Device ID | K083389 |
| 510k Number | K083389 |
| Device Name: | COALITION SPACER |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| 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 | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-17 |
| Decision Date | 2009-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044007800 | K083389 | 000 |
| 00849044007527 | K083389 | 000 |
| 00849044007534 | K083389 | 000 |
| 00849044007541 | K083389 | 000 |
| 00849044007558 | K083389 | 000 |
| 00849044007565 | K083389 | 000 |
| 00849044007572 | K083389 | 000 |
| 00849044007589 | K083389 | 000 |
| 00849044007596 | K083389 | 000 |
| 00849044007510 | K083389 | 000 |
| 00849044007503 | K083389 | 000 |
| 00849044007428 | K083389 | 000 |
| 00849044007435 | K083389 | 000 |
| 00849044007442 | K083389 | 000 |
| 00849044007459 | K083389 | 000 |
| 00849044007466 | K083389 | 000 |
| 00849044007473 | K083389 | 000 |
| 00849044007480 | K083389 | 000 |
| 00849044007497 | K083389 | 000 |
| 00849044007602 | K083389 | 000 |
| 00849044007619 | K083389 | 000 |
| 00849044007725 | K083389 | 000 |
| 00849044007732 | K083389 | 000 |
| 00849044007749 | K083389 | 000 |
| 00849044007756 | K083389 | 000 |
| 00849044007763 | K083389 | 000 |
| 00849044007770 | K083389 | 000 |
| 00849044007787 | K083389 | 000 |
| 00849044007794 | K083389 | 000 |
| 00849044007718 | K083389 | 000 |
| 00849044007701 | K083389 | 000 |
| 00849044007626 | K083389 | 000 |
| 00849044007633 | K083389 | 000 |
| 00849044007640 | K083389 | 000 |
| 00849044007657 | K083389 | 000 |
| 00849044007664 | K083389 | 000 |
| 00849044007671 | K083389 | 000 |
| 00849044007688 | K083389 | 000 |
| 00849044007695 | K083389 | 000 |
| 00849044007411 | K083389 | 000 |