TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET— 510(k) K093127
Substantially EquivalentZimmer Trabecular Metal Technology
FDA 510(k) clearance K093127 for TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET, Substantially Equivalent on 2010-03-04. Applicant: Zimmer Trabecular Metal Technology. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular Metal Technology
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Recent devices under product code MQP
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 MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
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.