BIOLOX DELTA OPTION CERAMIC HEADS— 510(k) K082996
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K082996 for BIOLOX DELTA OPTION CERAMIC HEADS, Substantially Equivalent on 2009-01-15. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code LZO
view allMore clearances from Biomet, Inc.
view allAdverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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 →
Recalls naming K082996
K-number listed on FDA's recall record- Z-3132-2024 — Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
- Z-3133-2024 — Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
- Z-0301-2018 — CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
- Z-0302-2018 — CER BIOLOXD OPTION HD 32MM, model # 650-1056
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082996.
Data sourced from openFDA. This site is unofficial and independent of the FDA.