FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)— 510(k) K031401
Substantially EquivalentDisco-O-Tech Medical Technologies, Ltd.
FDA 510(k) clearance K031401 for FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS), Substantially Equivalent on 2003-08-06. Applicant: Disco-O-Tech Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Herzlia, IL
Recent devices under product code KTT
view allMore clearances from Disco-O-Tech Medical Technologies, Ltd.
view all- K032588 — MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
- K023437 — FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL
- K021324 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
- K012967 — MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
- K003212 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
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.