THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330— 510(k) K032344
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K032344 for THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330, Substantially Equivalent on 2003-10-02. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- Product code
- Code EZX
- 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 EZX
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
- K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
Data sourced from openFDA. This site is unofficial and independent of the FDA.