ENSPLINT TM BONE SCREW— 510(k) K080778
Substantially EquivalentSonoma Orthopedic Products, Inc.
FDA 510(k) clearance K080778 for ENSPLINT TM BONE SCREW, Substantially Equivalent on 2008-07-10. Applicant: Sonoma Orthopedic Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonoma Orthopedic Products, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Rosa, CA, US
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Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.