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FDA 510(k), K001374, PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
FDA 510(k), K001374, PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
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510(K) Number: K001374
Device Name: PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
Manufacturer: BIOMET MANUFACTURING, INC.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 05/01/2000
Decision Date: 07/27/2000
Regulation Medical Specialty: Orthopedic
Device Name: PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
Manufacturer: BIOMET MANUFACTURING, INC.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 05/01/2000
Decision Date: 07/27/2000
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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