The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Lesplasty Posterior Cervical Laminoplasty System.
| Device ID | K132740 |
| 510k Number | K132740 |
| Device Name: | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Contact | Paul L Speidel |
| Correspondent | Paul L Speidel SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-11-26 |
| Summary: | summary |