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FDA 510(k), K112470, 2GC HIP/KNEE MODULAR SPACER
FDA 510(k), K112470, 2GC HIP/KNEE MODULAR SPACER
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510(K) Number: K112470
Device Name: 2GC HIP/KNEE MODULAR SPACER
Manufacturer: MANDELL HORWITZ CONSULTANTS LLC
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 08/26/2011
Decision Date: 04/05/2012
Regulation Medical Specialty: Orthopedic
Device Name: 2GC HIP/KNEE MODULAR SPACER
Manufacturer: MANDELL HORWITZ CONSULTANTS LLC
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 08/26/2011
Decision Date: 04/05/2012
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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