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FDA 510(k), K082446, BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
FDA 510(k), K082446, BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
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510(K) Number: K082446
Device Name: BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Number: 888.3330
Classification Product Code: KWA
Date Received: 08/25/2008
Decision Date: 10/15/2008
Regulation Medical Specialty: Orthopedic
Device Name: BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Number: 888.3330
Classification Product Code: KWA
Date Received: 08/25/2008
Decision Date: 10/15/2008
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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