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FDA 510(k), K113447, RISE SPACER
FDA 510(k), K113447, RISE SPACER
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510(K) Number: K113447
Device Name: RISE SPACER
Manufacturer: KELLY J BAKER
Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation Number: MAX
Classification Product Code: KXA
Date Received: 11/21/2011
Decision Date: 01/26/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: RISE SPACER
Manufacturer: KELLY J BAKER
Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation Number: MAX
Classification Product Code: KXA
Date Received: 11/21/2011
Decision Date: 01/26/2012
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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