THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM— 510(k) K023882
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K023882 for THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, Substantially Equivalent on 2003-02-19. 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
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code EZX
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- 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.