The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Sustain Radiolucent Spacer.
| Device ID | K040284 |
| 510k Number | K040284 |
| Device Name: | SUSTAIN RADIOLUCENT SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | GLOBUS MEDICAL, INC. 303 SCHELL LANE Phoenixville, PA 19460 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 303 SCHELL LANE Phoenixville, PA 19460 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044078527 | K040284 | 000 |
| 00849044078510 | K040284 | 000 |
| 00849044078503 | K040284 | 000 |
| 00849044078497 | K040284 | 000 |
| 00849044078480 | K040284 | 000 |
| 00849044078473 | K040284 | 000 |
| 00849044078466 | K040284 | 000 |
| 00849044078459 | K040284 | 000 |