The following data is part of a premarket notification filed by Globe Medical, Inc. with the FDA for Sustain And Sustain Radiolucent Spacers.
| Device ID | K130478 |
| 510k Number | K130478 |
| Device Name: | SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GLOBE MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Sarah Marie Fitzgerald |
| Correspondent | Sarah Marie Fitzgerald GLOBE MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095215267 | K130478 | 000 |
| 00889095208313 | K130478 | 000 |
| 00889095208306 | K130478 | 000 |
| 00889095208290 | K130478 | 000 |
| 00889095208283 | K130478 | 000 |
| 00889095208276 | K130478 | 000 |
| 00889095208269 | K130478 | 000 |
| 00889095208252 | K130478 | 000 |
| 00889095208245 | K130478 | 000 |
| 00889095208238 | K130478 | 000 |
| 00889095208221 | K130478 | 000 |
| 00889095208214 | K130478 | 000 |
| 00889095208207 | K130478 | 000 |
| 00889095208191 | K130478 | 000 |
| 00889095208320 | K130478 | 000 |
| 00889095208337 | K130478 | 000 |
| 00889095215250 | K130478 | 000 |
| 00889095215243 | K130478 | 000 |
| 00889095215236 | K130478 | 000 |
| 00889095215229 | K130478 | 000 |
| 00889095215212 | K130478 | 000 |
| 00889095215205 | K130478 | 000 |
| 00889095215199 | K130478 | 000 |
| 00889095208399 | K130478 | 000 |
| 00889095208382 | K130478 | 000 |
| 00889095208375 | K130478 | 000 |
| 00889095208368 | K130478 | 000 |
| 00889095208351 | K130478 | 000 |
| 00889095208344 | K130478 | 000 |
| 00889095208184 | K130478 | 000 |