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FDA 510(k), K163397, SMR Hybrid Glenoid System
FDA 510(k), K163397, SMR Hybrid Glenoid System
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510(K) Number: K163397
Device Name: SMR Hybrid Glenoid System
Manufacturer: Limacorporate S.p.A.
Device Classification Name: prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Number: 888.3670
Classification Product Code: MBF
Date Received: 12/05/2016
Decision Date: 06/29/2017
Regulation Medical Specialty: Orthopedic
Device Name: SMR Hybrid Glenoid System
Manufacturer: Limacorporate S.p.A.
Device Classification Name: prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Number: 888.3670
Classification Product Code: MBF
Date Received: 12/05/2016
Decision Date: 06/29/2017
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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