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FDA 510(k), K171858, Sidus Stem-Free Shoulder
FDA 510(k), K171858, Sidus Stem-Free Shoulder
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510(K) Number: K171858
Device Name: Sidus Stem-Free Shoulder
Manufacturer: Zimmer GmbH
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: 06/21/2017
Decision Date: 12/18/2017
Regulation Medical Specialty: Orthopedic
Device Name: Sidus Stem-Free Shoulder
Manufacturer: Zimmer GmbH
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: 06/21/2017
Decision Date: 12/18/2017
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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