The following data is part of a premarket notification filed by Medical Designs, Llc with the FDA for Asfora Anterior Cervical Plate System.
| Device ID | K143688 |
| 510k Number | K143688 |
| Device Name: | ASFORA ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDICAL DESIGNS, LLC 6709 S. MINNESOTA AVE., SUITE 204 Sioux Falls, SD 57108 |
| Contact | Kristi Vondra |
| Correspondent | Kristi Vondra MEDICAL DESIGNS, LLC 6709 S. MINNESOTA AVE., SUITE 204 Sioux Falls, SD 57108 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 111106273 | K143688 | 000 |
| 111106354 | K143688 | 000 |
| 111106351 | K143688 | 000 |
| 111106250 | K143688 | 000 |
| 111106247 | K143688 | 000 |
| 111106244 | K143688 | 000 |
| 111106241 | K143688 | 000 |
| 111106238 | K143688 | 000 |
| 111106235 | K143688 | 000 |
| 111106232 | K143688 | 000 |
| 111106134 | K143688 | 000 |
| 111106132 | K143688 | 000 |
| 111106130 | K143688 | 000 |
| 111106128 | K143688 | 000 |
| 111106126 | K143688 | 000 |
| 111106124 | K143688 | 000 |
| 111106122 | K143688 | 000 |
| 111106357 | K143688 | 000 |
| 111106360 | K143688 | 000 |
| 111106363 | K143688 | 000 |
| 111106272 | K143688 | 000 |
| 111106271 | K143688 | 000 |
| 11110641 | K143688 | 000 |
| 11110629 | K143688 | 000 |
| 11110643 | K143688 | 000 |
| 11110642 | K143688 | 000 |
| 111106494 | K143688 | 000 |
| 111106490 | K143688 | 000 |
| 111106486 | K143688 | 000 |
| 111106482 | K143688 | 000 |
| 111106478 | K143688 | 000 |
| 111106474 | K143688 | 000 |
| 111106375 | K143688 | 000 |
| 111106372 | K143688 | 000 |
| 111106369 | K143688 | 000 |
| 111106366 | K143688 | 000 |
| M364111106FD1200 | K143688 | 000 |