AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM— 510(k) K112615
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K112615 for AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM, Substantially Equivalent on 2011-10-11. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Edina, MN, US
Recent devices under product code PHX
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 PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
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.