4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM— 510(k) K110354
Substantially EquivalentSynthes USA
FDA 510(k) clearance K110354 for 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM, Substantially Equivalent on 2011-03-04. Applicant: Synthes USA. Device class: 2.
Clearance details
- Applicant
- Synthes USA
- Product code
- Code JDP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Chester, PA, US
Recent devices under product code JDP
view allMore clearances from Synthes USA
view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM
- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Adverse events under product code JDP
product code JDP- Injury
- 206
- Total
- 206
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 K110354
K-number listed on FDA's recall record- Z-1125-2014 — Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
- Z-0401-2014 — Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110354.
Data sourced from openFDA. This site is unofficial and independent of the FDA.