TRILOGY LONGEVITY CONSTRAINED LINER— 510(k) K071718
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K071718 for TRILOGY LONGEVITY CONSTRAINED LINER, Substantially Equivalent on 2007-07-13. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code KWZ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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- 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 KWZ
product code KWZ- Injury
- 993
- Total
- 993
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 K071718
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 K071718.
Data sourced from openFDA. This site is unofficial and independent of the FDA.