The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Spectrum Spine Laminoplasty Plating System.
| Device ID | K122822 |
| 510k Number | K122822 |
| Device Name: | SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | SPECTRUM SPINE, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May SPECTRUM SPINE, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2013-02-07 |
| Summary: | summary |