The following data is part of a premarket notification filed by Medical Designs, Llc with the FDA for Fixated Asfora Bullet Cage® (fabc).
| Device ID | K181591 |
| 510k Number | K181591 |
| Device Name: | Fixated Asfora BULLET CAGE® (FABC) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2018-09-26 |
| Summary: | summary |