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510(k) Data Aggregation
K Number
K092670Device Name
BIODRIVE MICRO SCREW SYSTEM
Manufacturer
EBI,LLC D/B/A BIOMET TRAUMA
Date Cleared
2009-11-19
(80 days)
Product Code
HRS, HWC, PAG
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EBI,LLC D/B/A BIOMET TRAUMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
- Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
- Ligament reconstruction
- Osteochondritis dissecans
- Arthrodesis of the foot, ankle, wrist, elbow and hand
- Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Device Description
The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.
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