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FDA 510(k), K143552, Simpliciti Shoulder System
FDA 510(k), K143552, Simpliciti Shoulder System
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510(K) Number: K143552
Device Name: Simpliciti Shoulder System
Manufacturer: TORNIER, INC.
Device Classification Name: prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Regulation Number: 888.3660
Classification Product Code: PKC
Date Received: 12/15/2014
Decision Date: 03/04/2015
Regulation Medical Specialty: Orthopedic
Device Name: Simpliciti Shoulder System
Manufacturer: TORNIER, INC.
Device Classification Name: prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Regulation Number: 888.3660
Classification Product Code: PKC
Date Received: 12/15/2014
Decision Date: 03/04/2015
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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