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FDA 510(k), K061451, ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
FDA 510(k), K061451, ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
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510(K) Number: K061451
Device Name: ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
Manufacturer: ASCENSION ORTHOPEDICS, INC.
Device Classification Name: prosthesis, wrist, carpal trapezium
Regulation Number: 888.3770
Classification Product Code: KYI
Date Received: 05/25/2006
Decision Date: 08/11/2006
Regulation Medical Specialty: Orthopedic
Device Name: ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
Manufacturer: ASCENSION ORTHOPEDICS, INC.
Device Classification Name: prosthesis, wrist, carpal trapezium
Regulation Number: 888.3770
Classification Product Code: KYI
Date Received: 05/25/2006
Decision Date: 08/11/2006
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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