DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS— 510(k) K033329
Substantially EquivalentDepuy, Inc.
FDA 510(k) clearance K033329 for DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS, Substantially Equivalent on 2003-11-14. Applicant: Depuy, Inc.. Device class: 2.
Clearance details
- Applicant
- Depuy, Inc.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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More clearances from Depuy, Inc.
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.