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FDA 510(k), K072020, RESTORATION ADM SYSTEM
FDA 510(k), K072020, RESTORATION ADM SYSTEM
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510(K) Number: K072020
Device Name: RESTORATION ADM SYSTEM
Manufacturer: HOWMEDICA OSTEONICS CORP
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: 888.3353
Classification Product Code: MEH
Date Received: 07/23/2007
Decision Date: 10/18/2007
Regulation Medical Specialty: Orthopedic
Device Name: RESTORATION ADM SYSTEM
Manufacturer: HOWMEDICA OSTEONICS CORP
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: 888.3353
Classification Product Code: MEH
Date Received: 07/23/2007
Decision Date: 10/18/2007
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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