TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS— 510(k) K053340
Substantially EquivalentZimmer Trabecular
FDA 510(k) clearance K053340 for TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS, Substantially Equivalent on 2006-02-27. Applicant: Zimmer Trabecular. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code MBH
view allMore clearances from Zimmer Trabecular
view all- K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
- K061067 — TRABECULAR METAL ACETABULAR AUGMENTS
- K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
- K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
- K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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.