ArthrexVIP Web Portal— 510(k) K153612
Substantially EquivalentCustom Orthopaedic Solutions, Inc.
FDA 510(k) clearance K153612 for ArthrexVIP Web Portal, Substantially Equivalent on 2016-03-15. Applicant: Custom Orthopaedic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Custom Orthopaedic Solutions, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code LLZ
view allMore clearances from Custom Orthopaedic Solutions, Inc.
view all- K162697 — Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
- K153215 — SmartBase for Arthrex Glenoid IRIS
- K151501 — OrthoVis Web Portal
- K151568 — Arthrex OrthoVis Preoperative Plan
- K142072 — GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.