THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10— 510(k) K050101
Substantially EquivalentZimmer Trabecular
FDA 510(k) clearance K050101 for THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10, Substantially Equivalent on 2005-04-15. Applicant: Zimmer Trabecular. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code HRS
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 HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.