DISTAL RADIUS FRACTURE REPAIR SYSTEM— 510(k) K032705
Substantially EquivalentHand Innovations, Inc.
FDA 510(k) clearance K032705 for DISTAL RADIUS FRACTURE REPAIR SYSTEM, Substantially Equivalent on 2003-10-01. Applicant: Hand Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Hand Innovations, Inc.
- Product code
- Code LXT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Lakes, FL, US
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