The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sustain Spacer.
| Device ID | K031302 |
| 510k Number | K031302 |
| Device Name: | SUSTAIN SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460 |
| Contact | Daniel S Paul |
| Correspondent | Daniel S Paul GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-24 |
| Decision Date | 2003-06-27 |
| Summary: | summary |