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FDA 510(k), K161190, G7 Dual Mobility System, Active Articulation System
FDA 510(k), K161190, G7 Dual Mobility System, Active Articulation System
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510(K) Number: K161190
Device Name: G7 Dual Mobility System, Active Articulation System
Manufacturer: Biomet, Inc
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 04/27/2016
Decision Date: 05/26/2016
Regulation Medical Specialty: Orthopedic
Device Name: G7 Dual Mobility System, Active Articulation System
Manufacturer: Biomet, Inc
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 04/27/2016
Decision Date: 05/26/2016
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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