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FDA 510(k), K001350, PATIENT MATCHED TITANIUM ALLOY TROCHLEA
FDA 510(k), K001350, PATIENT MATCHED TITANIUM ALLOY TROCHLEA
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510(K) Number: K001350
Device Name: PATIENT MATCHED TITANIUM ALLOY TROCHLEA
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 04/28/2000
Decision Date: 07/26/2000
Regulation Medical Specialty: Orthopedic
Device Name: PATIENT MATCHED TITANIUM ALLOY TROCHLEA
Manufacturer: BIOMET, INC.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 04/28/2000
Decision Date: 07/26/2000
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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