FIXION HIP SYSTEM— 510(k) K032730
Substantially EquivalentDisc-O-Tech Medical Technologies, Ltd.
FDA 510(k) clearance K032730 for FIXION HIP SYSTEM, Substantially Equivalent on 2004-03-26. Applicant: Disc-O-Tech Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Herzelia, IL
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More clearances from Disc-O-Tech Medical Technologies, Ltd.
view allAdverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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.