Alliance Augmented Glenoid— 510(k) K193180
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K193180 for Alliance Augmented Glenoid, Substantially Equivalent on 2020-02-24. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, 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
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KWS
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
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.