CraniUS Plate— 510(k) K261058
Substantially EquivalentCraniUS, LLC
FDA 510(k) clearance K261058 for CraniUS Plate, Substantially Equivalent on 2026-07-29. Applicant: CraniUS, LLC. Device class: 2.
Clearance details
- Applicant
- CraniUS, LLC
- Product code
- Code GWO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code GWO
view all- K250297 — TECHFIT Patient-Specific Cranial System
- K250334 — Fusion Craniofacial Implant; Fusion Skull Implant
- K231834 — VSP PEEK Cranial Implant
- K212391 — MCI-Neuro Fixation System
- K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.