ForeFoot STP System— 510(k) K150871
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K150871 for ForeFoot STP System, Substantially Equivalent on 2015-08-04. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medina, OH, US
Recent devices under product code HWC
view allMore clearances from Tornier, Inc.
view all- K263583 — Tornier Humeral Reconstruction System (HRS) Tuberosity Body
- K260721 — Tornier Perform Advanced Glenoid
- K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.