The following data is part of a premarket notification filed by Medical Design Llc. with the FDA for Asfora Anterior Cervical Plate System, One Level, 14mm Asfora Anterior Cervical Plate System, One Level, 16mm.
| Device ID | K122497 |
| 510k Number | K122497 |
| Device Name: | ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDICAL DESIGN LLC. 6709 S. MINNESOTA AVE. STE 204 Sioux Falls, SD 57108 -2593 |
| Contact | Kristi Vondra |
| Correspondent | Kristi Vondra MEDICAL DESIGN LLC. 6709 S. MINNESOTA AVE. STE 204 Sioux Falls, SD 57108 -2593 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2012-10-15 |
| Summary: | summary |