ARICULATED TENSION DEVICE SYNTHES TEN— 510(k) K792253
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K792253 for ARICULATED TENSION DEVICE SYNTHES TEN, Substantially Equivalent on 1979-12-05. Applicant: Synthes (Usa). Device class: 1.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code HWN
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code HWN
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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 HWN
product code HWN- Malfunction
- 586
- Total
- 586
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.