The following data is part of a premarket notification filed by Eminent Spine with the FDA for Diamond Rattlesnake System.
| Device ID | K133194 |
| 510k Number | K133194 |
| Device Name: | DIAMOND RATTLESNAKE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EMINENT SPINE 7828 HICKORY FLAT HWY, STE 120 Woodstock, GA 30188 |
| Contact | Linda Braddon |
| Correspondent | Linda Braddon EMINENT SPINE 7828 HICKORY FLAT HWY, STE 120 Woodstock, GA 30188 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B014BD5555 | K133194 | 000 |
| B014BD123 | K133194 | 000 |
| B014BD125 | K133194 | 000 |
| B014BD127 | K133194 | 000 |
| B014BD129 | K133194 | 000 |
| B014BD131 | K133194 | 000 |
| B014BD133 | K133194 | 000 |
| B014BD5525 | K133194 | 000 |
| B014BD5530 | K133194 | 000 |
| B014BD5535 | K133194 | 000 |
| B014BD5540 | K133194 | 000 |
| B014BD5545 | K133194 | 000 |
| B014BD5550 | K133194 | 000 |
| B014BD121 | K133194 | 000 |