The following data is part of a premarket notification filed by Eminent Spine with the FDA for King Cobra Anterior Cervical Plate.
| Device ID | K103068 |
| 510k Number | K103068 |
| Device Name: | KING COBRA ANTERIOR CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EMINENT SPINE 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden EMINENT SPINE 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B014KCP141 | K103068 | 000 |
| B014KCP392 | K103068 | 000 |
| B014KCP4012 | K103068 | 000 |
| B014KCP4014 | K103068 | 000 |
| B014KCP4016 | K103068 | 000 |
| B014KCP4112 | K103068 | 000 |
| B014KCP4114 | K103068 | 000 |
| B014KCP4116 | K103068 | 000 |
| B014KCP4212 | K103068 | 000 |
| B014KCP4214 | K103068 | 000 |
| B014KCP362 | K103068 | 000 |
| B014KCP332 | K103068 | 000 |
| B014KCP161 | K103068 | 000 |
| B014KCP181 | K103068 | 000 |
| B014KCP201 | K103068 | 000 |
| B014KCP221 | K103068 | 000 |
| B014KCP241 | K103068 | 000 |
| B014KCP261 | K103068 | 000 |
| B014KCP281 | K103068 | 000 |
| B014KCP282 | K103068 | 000 |
| B014KCP302 | K103068 | 000 |
| B014KCP4216 | K103068 | 000 |
| B014KCP422 | K103068 | 000 |
| B014KCP623 | K103068 | 000 |
| B014KCP644 | K103068 | 000 |
| B014KCP653 | K103068 | 000 |
| B014KCP683 | K103068 | 000 |
| B014KCP713 | K103068 | 000 |
| B014KCP724 | K103068 | 000 |
| B014KCP764 | K103068 | 000 |
| B014KCP804 | K103068 | 000 |
| B014KCP844 | K103068 | 000 |
| B014KCP604 | K103068 | 000 |
| B014KCP593 | K103068 | 000 |
| B014KCP4312 | K103068 | 000 |
| B014KCP4314 | K103068 | 000 |
| B014KCP4316 | K103068 | 000 |
| B014KCP452 | K103068 | 000 |
| B014KCP473 | K103068 | 000 |
| B014KCP482 | K103068 | 000 |
| B014KCP503 | K103068 | 000 |
| B014KCP533 | K103068 | 000 |
| B014KCP563 | K103068 | 000 |
| B014KCP864 | K103068 | 000 |