Icona Hip Stem— 510(k) K261576
Substantially EquivalentCorin, Ltd.
FDA 510(k) clearance K261576 for Icona Hip Stem, Substantially Equivalent on 2026-08-10. Applicant: Corin, Ltd.. Device class: 2.
Clearance details
- Applicant
- Corin, Ltd.
- Product code
- Code MEH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cirencester, GB
Recent devices under product code MEH
view allMore clearances from Corin, Ltd.
view all- K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
- K200888 — OMNIBotics Knee System
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.