Simpliciti Shoulder System— 510(k) K143552
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K143552 for Simpliciti Shoulder System, Substantially Equivalent on 2015-03-04. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code PKC
- 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 PKC
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- 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 PKC
product code PKC- Injury
- 258
- Total
- 258
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.