# K141123: Alliance Spine Raas Cranial Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Partners, LLC
- Decided: Feb 27, 2015 after 302 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K761228 (1976). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031659: Universal Neuro System, Stryker Instruments (2003) Summary page 4.
- K111176: Osteomed Low Profile Neuro Fixation System, Osteomed LP (2011) Summary page 4.

## Indications for use
The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, craniotomy, cranial fractures, and reconstruction of non-load bearing cranial areas.

Source page: https://510kreport.com/device/K141123
Methodology: https://510kreport.com/methodology