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FDA 510(k), K081122, FUSION MEDICAL CANNULATED SCREW SYSTEM
FDA 510(k), K081122, FUSION MEDICAL CANNULATED SCREW SYSTEM
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510(K) Number: K081122
Device Name: FUSION MEDICAL CANNULATED SCREW SYSTEM
Manufacturer: JOHN RICCIO
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: KXA
Date Received: 04/21/2008
Decision Date: 05/26/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: FUSION MEDICAL CANNULATED SCREW SYSTEM
Manufacturer: JOHN RICCIO
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: KXA
Date Received: 04/21/2008
Decision Date: 05/26/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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