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FDA 510(k), K190834, Corin Optimized Position System Functional Hip Analysis (OPS FHA)
FDA 510(k), K190834, Corin Optimized Position System Functional Hip Analysis (OPS FHA)
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510(K) Number: K190834
Device Name: Corin Optimized Position System Functional Hip Analysis (OPS FHA)
Manufacturer: Lucinda Gerber
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: 04/01/2019
Date Received: 07/22/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Corin Optimized Position System Functional Hip Analysis (OPS FHA)
Manufacturer: Lucinda Gerber
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: LZO
Classification Product Code: 04/01/2019
Date Received: 07/22/2019
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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