TRABECULAR METAL TIBIAL CONE AUGMENTS— 510(k) K102896
Substantially EquivalentZimmer Trabecular Metal Technology
FDA 510(k) clearance K102896 for TRABECULAR METAL TIBIAL CONE AUGMENTS, Substantially Equivalent on 2010-12-13. Applicant: Zimmer Trabecular Metal Technology. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular Metal Technology
- 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
- Parsippany, NJ, US
Recent devices under product code MBH
view allMore clearances from Zimmer Trabecular Metal Technology
view all- K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
- K123602 — TM ARDIS INTERBODY SYSTEM INSERTER
- K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
- K113561 — TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
- K111983 — VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
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.