The following data is part of a premarket notification filed by Biotechni America Spine Group, Inc. with the FDA for Solas Anatomix Spinal System.
| Device ID | K083178 |
| 510k Number | K083178 |
| Device Name: | SOLAS ANATOMIX SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | BIOTECHNI AMERICA SPINE GROUP, INC. 13203 39TH AVE. NE Seattle, WA 98125 -4615 |
| Contact | Daniel R Baker |
| Correspondent | Daniel R Baker BIOTECHNI AMERICA SPINE GROUP, INC. 13203 39TH AVE. NE Seattle, WA 98125 -4615 |
| Product Code | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-02-23 |
| Summary: | summary |