Biomet Spine (Aka Ebi, LLC) · Class II · Cleared Jul 20, 2010
| K-number | K100805 |
| Device name | GALLERY LAMINOPLASTY FIXATION SYSTEM |
| Applicant | Biomet Spine (Aka Ebi, LLC) |
| Product code | NQW |
| Device class | Class II |
| Decision date | Jul 20, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 888.3050 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov