The following data is part of a premarket notification filed by Biomet Spine (aka Ebi, Llc) with the FDA for Gallery Laminoplasty Fixation System.
| Device ID | K100805 |
| 510k Number | K100805 |
| Device Name: | GALLERY LAMINOPLASTY FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Shikha Gola |
| Correspondent | Shikha Gola BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-07-20 |
| Summary: | summary |