CORIN METAFIX FEMORAL STEM— 510(k) K082525
Substantially EquivalentCorin USA
FDA 510(k) clearance K082525 for CORIN METAFIX FEMORAL STEM, Substantially Equivalent on 2010-02-04. Applicant: Corin USA. Device class: 2.
Clearance details
- Applicant
- Corin USA
- 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
- Traditional
- Location
- Tampa, FL, US
Recent devices under product code LZO
view allMore clearances from Corin USA
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 K082525
K-number listed on FDA's recall record- Z-1509-2022 — Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
- Z-2609-2021 — Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082525.
Data sourced from openFDA. This site is unofficial and independent of the FDA.