TM ARDIS INTERBODY SYSTEM INSERTER— 510(k) K123602
Substantially EquivalentZimmer Trabecular Metal Technology
FDA 510(k) clearance K123602 for TM ARDIS INTERBODY SYSTEM INSERTER, Substantially Equivalent on 2013-03-01. Applicant: Zimmer Trabecular Metal Technology. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular Metal Technology
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Recent devices under product code MAX
view allMore clearances from Zimmer Trabecular Metal Technology
view all- K133784 — VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
- 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
- K103033 — TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.