The following data is part of a premarket notification filed by Safeop Surgical, Inc. with the FDA for The Epad 2 System.
| Device ID | K182542 |
| 510k Number | K182542 |
| Device Name: | The EPAD 2 System |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | SafeOp Surgical, Inc. 11350 McCormick Rd, Suite 1003 Hunt Valley, MD 21031 |
| Contact | Richard O'brien |
| Correspondent | Jeremy Markovich Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | GWF |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GXY |
| Subsequent Product Code | GXZ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | PDQ |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376234762 | K182542 | 000 |
| 00190376180359 | K182542 | 000 |
| 00190376180342 | K182542 | 000 |
| 00190376331614 | K182542 | 000 |
| 00190376331607 | K182542 | 000 |
| 00190376331591 | K182542 | 000 |
| 00190376330723 | K182542 | 000 |
| 00190376275796 | K182542 | 000 |
| 00190376275789 | K182542 | 000 |
| 00190376275772 | K182542 | 000 |
| 00190376180373 | K182542 | 000 |
| 00190376192277 | K182542 | 000 |
| 00190376192376 | K182542 | 000 |
| 00190376234755 | K182542 | 000 |
| 00190376234007 | K182542 | 000 |
| 00190376233994 | K182542 | 000 |
| 00190376233987 | K182542 | 000 |
| 00190376233970 | K182542 | 000 |
| 00190376233963 | K182542 | 000 |
| 00190376192406 | K182542 | 000 |
| 00190376192390 | K182542 | 000 |
| 00190376192383 | K182542 | 000 |
| 00190376275765 | K182542 | 000 |