DEROYAL NON-LOCKING BONE FIXATION SYSTEM— 510(k) K090975
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K090975 for DEROYAL NON-LOCKING BONE FIXATION SYSTEM, Substantially Equivalent on 2010-04-12. Applicant: Deroyal Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Powell, TN, US
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Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.