TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N— 510(k) K133081
Substantially EquivalentAdvanced Orthopaedic Solutions, Inc.
FDA 510(k) clearance K133081 for TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N, Substantially Equivalent on 2013-12-31. Applicant: Advanced Orthopaedic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Orthopaedic Solutions, Inc.
- Product code
- Product 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
- Torrance, CA, US
Recent devices under product code HSB
view allMore clearances from Advanced Orthopaedic Solutions, 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.