DARCO LOCKING BONE PLATE SYSTEM— 510(k) K061808
Substantially EquivalentDarco International, Inc.
FDA 510(k) clearance K061808 for DARCO LOCKING BONE PLATE SYSTEM, Substantially Equivalent on 2006-08-17. Applicant: Darco International, Inc.. Device class: 2.
Clearance details
- Applicant
- Darco International, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntington, WV, US
Recent devices under product code HRS
view allMore clearances from Darco International, Inc.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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 K061808
K-number listed on FDA's recall record- Z-0679-2022 — The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
- Z-0393-2022 — Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Z-0573-2020 — CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061808.
Data sourced from openFDA. This site is unofficial and independent of the FDA.