SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM— 510(k) K050041
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K050041 for SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM, Substantially Equivalent on 2005-02-25. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code JDQ
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view all- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
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- 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 JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
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.