EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM— 510(k) K050766
Substantially EquivalentZimmer Trabecular
FDA 510(k) clearance K050766 for EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM, Substantially Equivalent on 2005-05-26. Applicant: Zimmer Trabecular. Device class: 1.
Clearance details
- Applicant
- Zimmer Trabecular
- Product code
- Code HWE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code HWE
view allMore clearances from Zimmer Trabecular
view all- K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
- K061067 — TRABECULAR METAL ACETABULAR AUGMENTS
- K053340 — TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
- K052950 — THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
- K051756 — MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
Adverse events under product code HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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.