SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES— 510(k) K042895
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K042895 for SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES, Substantially Equivalent on 2004-11-16. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Product code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Paoli, PA, US
Recent devices under product code KTT
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- 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 KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.