The following data is part of a premarket notification filed by Medical Designs, Llc with the FDA for Asfora Bullet Cage System.
| Device ID | K090048 |
| 510k Number | K090048 |
| Device Name: | ASFORA BULLET CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDICAL DESIGNS, LLC 1210 W. 18TH ST. NORTH CENTER, SUITE 104 Sioux Falls, SD 57104 |
| Contact | Kristi Vondra |
| Correspondent | Kristi Vondra MEDICAL DESIGNS, LLC 1210 W. 18TH ST. NORTH CENTER, SUITE 104 Sioux Falls, SD 57104 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-07 |
| Decision Date | 2009-08-14 |
| Summary: | summary |