THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX— 510(k) K040756
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K040756 for THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX, Substantially Equivalent on 2004-07-14. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Allendale, NJ, US
Recent devices under product code FTM
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
- K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTS
- K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- K031962 — NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.