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FDA 510(k), K131467, ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k), K131467, ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
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510(K) Number: K131467
Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Manufacturer: CONFORMIS, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 05/21/2013
Decision Date: 07/18/2013
Regulation Medical Specialty: Orthopedic
Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Manufacturer: CONFORMIS, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 05/21/2013
Decision Date: 07/18/2013
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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