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FDA 510(k), K112030, SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
FDA 510(k), K112030, SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
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510(K) Number: K112030
Device Name: SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Manufacturer: ANGELA F LASSANDRO
Device Classification Name: Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation Number: KWI
Classification Product Code: 07/15/2011
Date Received: 06/19/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Manufacturer: ANGELA F LASSANDRO
Device Classification Name: Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation Number: KWI
Classification Product Code: 07/15/2011
Date Received: 06/19/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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