MyShoulder Planner (5.3SSWPL)— 510(k) K241292
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K241292 for MyShoulder Planner (5.3SSWPL), Substantially Equivalent on 2025-01-30. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code KWS
view all- K260721 — Tornier Perform Advanced Glenoid
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252418 — Catalyst F1x Shoulder System
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
More clearances from Medacta International S.A.
view allAdverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.