TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155— 510(k) K070754
Substantially EquivalentZimmer Trabecular Metal Technology
FDA 510(k) clearance K070754 for TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155, Substantially Equivalent on 2007-08-31. 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
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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.