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FDA 510(k), K855183, COFIELD SHOULDER SYSTEM
FDA 510(k), K855183, COFIELD SHOULDER SYSTEM
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510(K) Number: K855183
Device Name: COFIELD SHOULDER SYSTEM
Manufacturer: ROBERT F GAMES
Device Classification Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation Number: KWS
Classification Product Code: 12/26/1985
Date Received: 03/26/1986
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: COFIELD SHOULDER SYSTEM
Manufacturer: ROBERT F GAMES
Device Classification Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation Number: KWS
Classification Product Code: 12/26/1985
Date Received: 03/26/1986
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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