Mpact Constrained Liner— 510(k) K241461
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K241461 for Mpact Constrained Liner, Substantially Equivalent on 2025-07-31. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code KWZ
view all- K240639 — PINNACLETM Constrained Acetabular Liners
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
- K161610 — EXPRT Revision Hip System
- K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS
More clearances from Medacta International S.A.
view allAdverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
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.