INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid— 510(k) K230831
Substantially EquivalentDepuy Ireland UC
FDA 510(k) clearance K230831 for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid, Substantially Equivalent on 2023-11-13. Applicant: Depuy Ireland UC. Device class: 2.
Clearance details
- Applicant
- Depuy Ireland UC
- Product code
- Code MBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3670
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringaskiddy, IE
Recent devices under product code MBF
view all- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K251098 — Identity Revision Humeral Stems
- K250848 — Identity Shoulder System
- K240876 — Identity Shoulder System
- K233712 — PRIMA Humeral System; PRIMA TT Glenoid
More clearances from Depuy Ireland UC
view allAdverse events under product code MBF
product code MBF- Injury
- 597
- Total
- 597
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.