TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS— 510(k) K123705
Substantially EquivalentCorin USA
FDA 510(k) clearance K123705 for TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS, Substantially Equivalent on 2013-02-12. 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 K123705
K-number listed on FDA's recall record- Z-2605-2021 — Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
- Z-1526-2016 — Trinity Acetabular System Product Usage - Total Hip Replacement.
- Z-1527-2016 — Trinity Acetabular Shell Product Usage: Total Hip Replacement.
- Z-1528-2016 — Trinity Acetabular Shell Product Usage Total Hip Replacement.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123705.
Data sourced from openFDA. This site is unofficial and independent of the FDA.