SYNTHES STERILE DRILL BITS— 510(k) K962913
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K962913 for SYNTHES STERILE DRILL BITS, Substantially Equivalent on 1996-11-14. Applicant: Synthes (Usa). Device class: 1.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code HWE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code HWE
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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 HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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.