TITAN Modular Total Shoulder System— 510(k) K142413
Substantially EquivalentAscension Orthopedics
FDA 510(k) clearance K142413 for TITAN Modular Total Shoulder System, Substantially Equivalent on 2014-11-14. Applicant: Ascension Orthopedics. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedics
- 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
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWS
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- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K160830 — Integra External Fixation System
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.