Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)— 510(k) K241878
Substantially EquivalentStryker Corporation (Tornier, Inc.)
FDA 510(k) clearance K241878 for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem), Substantially Equivalent on 2024-12-06. Applicant: Stryker Corporation (Tornier, Inc.). Device class: 2.
Clearance details
- Applicant
- Stryker Corporation (Tornier, Inc.)
- 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
- Bloomington, MN, US
Recent devices under product code KWS
view allMore clearances from Stryker Corporation (Tornier, Inc.)
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.