The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Coalition Spacer.
| Device ID | K131449 |
| 510k Number | K131449 |
| Device Name: | COALITION SPACER |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula GLOBUS MEDICAL, INC. 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095214390 | K131449 | 000 |
| 00889095214581 | K131449 | 000 |
| 00889095214598 | K131449 | 000 |
| 00889095214604 | K131449 | 000 |
| 00889095214611 | K131449 | 000 |
| 00889095214628 | K131449 | 000 |
| 00889095214635 | K131449 | 000 |
| 00889095214642 | K131449 | 000 |
| 00889095214659 | K131449 | 000 |
| 00889095214574 | K131449 | 000 |
| 00889095214567 | K131449 | 000 |
| 00889095214550 | K131449 | 000 |
| 00889095214406 | K131449 | 000 |
| 00889095214413 | K131449 | 000 |
| 00889095214499 | K131449 | 000 |
| 00889095214505 | K131449 | 000 |
| 00889095214512 | K131449 | 000 |
| 00889095214529 | K131449 | 000 |
| 00889095214536 | K131449 | 000 |
| 00889095214543 | K131449 | 000 |
| 00889095214666 | K131449 | 000 |
| 00889095214673 | K131449 | 000 |
| 00889095214680 | K131449 | 000 |
| 00889095057294 | K131449 | 000 |
| 00889095057300 | K131449 | 000 |
| 00889095057317 | K131449 | 000 |
| 00849044093193 | K131449 | 000 |
| 00849044093209 | K131449 | 000 |
| 00849044093216 | K131449 | 000 |
| 00849044093223 | K131449 | 000 |
| 00849044093230 | K131449 | 000 |
| 00889095214796 | K131449 | 000 |
| 00889095214789 | K131449 | 000 |
| 00889095214772 | K131449 | 000 |
| 00889095214697 | K131449 | 000 |
| 00889095214703 | K131449 | 000 |
| 00889095214710 | K131449 | 000 |
| 00889095214727 | K131449 | 000 |
| 00889095214734 | K131449 | 000 |
| 00889095214741 | K131449 | 000 |
| 00889095214758 | K131449 | 000 |
| 00889095214765 | K131449 | 000 |
| 00849044093247 | K131449 | 000 |