HLS KNEETEC SYSTEM— 510(k) K094013
Substantially EquivalentTornier
FDA 510(k) clearance K094013 for HLS KNEETEC SYSTEM, Substantially Equivalent on 2011-05-05. Applicant: Tornier. Device class: 2.
Clearance details
- Applicant
- Tornier
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Monbonnot Saint Martin, FR
Recent devices under product code JWH
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
- K111902 — AEQUALIS SHOULDER SYSTEM
- K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K091870 — TORNIER, PITON FIXATION IMPLANT SYSTEM
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.