AEQUALIS SHOULDER SYSTEM— 510(k) K111902
Substantially EquivalentTornier
FDA 510(k) clearance K111902 for AEQUALIS SHOULDER SYSTEM, Substantially Equivalent on 2011-11-03. Applicant: Tornier. Device class: 2.
Clearance details
- Applicant
- Tornier
- 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
- Monbonnot Saint Martin, FR
Recent devices under product code KWS
view allMore clearances from Tornier
view all- K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
- K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
- K094013 — HLS KNEETEC SYSTEM
- K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K091870 — TORNIER, PITON FIXATION IMPLANT SYSTEM
Adverse 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.