TRABECULAR METAL KNEE SYSTEM AUGMENTS— 510(k) K040487
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K040487 for TRABECULAR METAL KNEE SYSTEM AUGMENTS, Substantially Equivalent on 2004-12-21. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- 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 Implex Corp.
view all- K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
- K051196 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
- K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
- K031962 — NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
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 →
Recalls naming K040487
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.