AEQUALIS FLEX REVIVE Shoulder System— 510(k) K191318
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K191318 for AEQUALIS FLEX REVIVE Shoulder System, Substantially Equivalent on 2019-06-14. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bloomington, MN, US
Recent devices under product code KWS
view allMore clearances from Tornier, Inc.
view allAdverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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 K191318
K-number listed on FDA's recall record- Z-2019-2023 — AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
- Z-2020-2023 — AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.