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FDA 510(k), K152754, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
FDA 510(k), K152754, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
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510(K) Number: K152754
Device Name: COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
Manufacturer: PATRICIA SANDBORN BERES
Device Classification Name: Shoulder Prosthesis, Reverse Configuration
Regulation Number: PHX
Classification Product Code: 09/24/2015
Date Received: 05/16/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
Manufacturer: PATRICIA SANDBORN BERES
Device Classification Name: Shoulder Prosthesis, Reverse Configuration
Regulation Number: PHX
Classification Product Code: 09/24/2015
Date Received: 05/16/2016
Decision Date: Substantially Equivalent (SESE)
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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