The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Canopy Laminoplasty Fixation System.
| Device ID | K121732 |
| 510k Number | K121732 |
| Device Name: | CANOPY LAMINOPLASTY FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Sarah Marie Fitzgerald |
| Correspondent | Sarah Marie Fitzgerald GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-13 |
| Decision Date | 2012-10-31 |
| Summary: | summary |