The following data is part of a premarket notification filed by Eminent Spine with the FDA for Eminent Spine Buttress (fang) Plate System.
| Device ID | K090415 |
| 510k Number | K090415 |
| Device Name: | EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | EMINENT SPINE 16001 RONALD REAGAN BLVD. Leander, TX 78641 |
| Contact | Dave Freehill |
| Correspondent | Dave Freehill EMINENT SPINE 16001 RONALD REAGAN BLVD. Leander, TX 78641 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2009-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B014FP1227 | K090415 | 000 |
| B014FP1225 | K090415 | 000 |
| B014FP1224 | K090415 | 000 |
| B014FP1220 | K090415 | 000 |