The following data is part of a premarket notification filed by Curiteva, Llc with the FDA for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System).
| Device ID | K181549 |
| 510k Number | K181549 |
| Device Name: | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Curiteva, LLC 25127 Will McComb Drive Suite 100 Tanner, AL 35671 |
| Contact | Eric Linder |
| Correspondent | Eric Linder Curiteva, LLC 25127 Will McComb Drive Suite 100 Tanner, AL 35671 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-12 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B648C16402420 | K181549 | 000 |
| B648C1558100 | K181549 | 000 |
| B648C1558000 | K181549 | 000 |
| B648C1557100 | K181549 | 000 |
| B648C1557000 | K181549 | 000 |
| B648C1556000 | K181549 | 000 |
| B648C155500180 | K181549 | 000 |
| B648C155500160 | K181549 | 000 |
| B648C155500140 | K181549 | 000 |
| B648C155500120 | K181549 | 000 |
| B648C1554100 | K181549 | 000 |
| B648C1554000 | K181549 | 000 |
| B648C155300100 | K181549 | 000 |
| B648C1552000 | K181549 | 000 |
| B648C15511000 | K181549 | 000 |
| B648C15510000 | K181549 | 000 |
| B648C1559000 | K181549 | 000 |
| B648C16401120 | K181549 | 000 |
| B648C16402400 | K181549 | 000 |
| B648C16402380 | K181549 | 000 |
| B648C16402360 | K181549 | 000 |
| B648C16402340 | K181549 | 000 |
| B648C16402320 | K181549 | 000 |
| B648C16402300 | K181549 | 000 |
| B648C16402280 | K181549 | 000 |
| B648C16402260 | K181549 | 000 |
| B648C16401260 | K181549 | 000 |
| B648C16401240 | K181549 | 000 |
| B648C16401220 | K181549 | 000 |
| B648C16401200 | K181549 | 000 |
| B648C16401180 | K181549 | 000 |
| B648C16401160 | K181549 | 000 |
| B648C16401140 | K181549 | 000 |
| B648C1551000 | K181549 | 000 |