SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM— 510(k) K120070
Substantially EquivalentSynthes USA
FDA 510(k) clearance K120070 for SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM, Substantially Equivalent on 2012-03-21. Applicant: Synthes USA. Device class: 2.
Clearance details
- Applicant
- Synthes USA
- 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
- West Chester, PA, US
Recent devices under product code HRS
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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 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 K120070
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120070.
Data sourced from openFDA. This site is unofficial and independent of the FDA.