The following data is part of a premarket notification filed by Alliance Partners, Llc. with the FDA for Alliance Spine Raas Cranial Plating System.
| Device ID | K141123 |
| 510k Number | K141123 |
| Device Name: | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | ALLIANCE PARTNERS, LLC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Tim Lohnes |
| Correspondent | Tim Lohnes ALLIANCE PARTNERS, LLC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2015-02-27 |
| Summary: | summary |