THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX— 510(k) K043061
Substantially EquivalentZimmer Trabecular
FDA 510(k) clearance K043061 for THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX, Substantially Equivalent on 2004-11-23. Applicant: Zimmer Trabecular. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular
- 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
- Allendale, NJ, US
Recent devices under product code KWS
view allMore clearances from Zimmer Trabecular
view all- K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
- K061067 — TRABECULAR METAL ACETABULAR AUGMENTS
- K053340 — TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
- K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
- K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
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.