MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE— 510(k) K990120
Substantially EquivalentDepuy Ace Medical Co.
FDA 510(k) clearance K990120 for MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE, Substantially Equivalent on 1999-02-01. Applicant: Depuy Ace Medical Co.. Device class: 2.
Clearance details
- Applicant
- Depuy Ace Medical Co.
- 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
- Special
- Location
- El Segundo, CA, US
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More clearances from Depuy Ace Medical Co.
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.