TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3— 510(k) K042871
Substantially EquivalentZimmer Trabecular
FDA 510(k) clearance K042871 for TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3, Substantially Equivalent on 2004-12-21. Applicant: Zimmer Trabecular. Device class: 2.
Clearance details
- Applicant
- Zimmer Trabecular
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Allendale, NJ, US
Recent devices under product code LPH
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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 LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.