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FDA 510(k), K053189, COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
FDA 510(k), K053189, COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
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510(K) Number: K053189
Device Name: COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
Manufacturer: LAURA D WILLIAMS
Device Classification Name: Prosthesis, Elbow, Constrained, Cemented
Regulation Number: JDC
Classification Product Code: KXA
Date Received: 11/15/2005
Decision Date: 12/09/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
Manufacturer: LAURA D WILLIAMS
Device Classification Name: Prosthesis, Elbow, Constrained, Cemented
Regulation Number: JDC
Classification Product Code: KXA
Date Received: 11/15/2005
Decision Date: 12/09/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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