PERFORM Humeral System Stem— 510(k) K201315
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K201315 for PERFORM Humeral System Stem, Substantially Equivalent on 2020-09-11. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code PAO
- 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
More 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 PAO
product code PAO- Injury
- 273
- Total
- 273
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 →
Recalls naming K201315
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201315.
Data sourced from openFDA. This site is unofficial and independent of the FDA.